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Review
. 2017 Nov 2;11(11):CD008528.
doi: 10.1002/14651858.CD008528.pub3.

Oral medications including clomiphene citrate or aromatase inhibitors with gonadotropins for controlled ovarian stimulation in women undergoing in vitro fertilisation

Mohan S Kamath  1 , Abha Maheshwari, Siladitya Bhattacharya, Kar Yee Lor, Ahmed Gibreel
Affiliations
Review

Oral medications including clomiphene citrate or aromatase inhibitors with gonadotropins for controlled ovarian stimulation in women undergoing in vitro fertilisation

Mohan S Kamath et al. Cochrane Database Syst Rev. .

Abstract

Background: Gonadotropins are the most commonly used medications for controlled ovarian stimulation in in vitro fertilisation (IVF). However, they are expensive and invasive, and are associated with the risk of ovarian hyperstimulation syndrome (OHSS). Recent calls for more patient-friendly regimens have led to growing interest in the use of clomiphene citrate (CC) and aromatase inhibitors with or without gonadotropins to reduce the burden of hormonal injections. It is currently unknown whether regimens using CC or aromatase inhibitors such as letrozole (Ltz) are as effective as gonadotropins alone.

Objectives: To determine the effectiveness and safety of regimens including oral induction medication (such as clomiphene citrate or letrozole) versus gonadotropin-only regimens for controlled ovarian stimulation in IVF or intracytoplasmic sperm injection (ICSI) treatment.

Search methods: We searched the following databases: Cochrane Gynaecology and Fertility Group Specialised Register (searched January 2017), the Cochrane Central Register of Controlled Trials (CENTRAL CRSO), MEDLINE (1946 to January 2017), Embase (1980 to January 2017), and reference lists of relevant articles. We also searched trials registries ClinicalTrials.gov (clinicaltrials.gov/) and the World Health Organization International Clinical Trials Registry Platform (www.who.int/trialsearch/Default.aspx). We handsearched relevant conference proceedings.

Selection criteria: We included randomized controlled trials (RCTs). The primary outcomes were live-birth rate (LBR) and OHSS.

Data collection and analysis: Three review authors independently assessed trial eligibility and risk of bias. We calculated risk ratios (RR) and Peto odds ratio (OR) with 95% confidence intervals (CIs) for dichotomous outcomes and mean differences (MD) for continuous outcomes. We analyzed the general population of women undergoing IVF treatment and (as a separate analysis) women identified as poor responders. We assessed the overall quality of the evidence using the GRADE approach.

Main results: We included 27 studies in the updated review. Most of the new trials in the updated review included poor responders and evaluated Ltz protocols. We could perform meta-analysis with data from 22 studies including a total of 3599 participants. The quality of the evidence for different comparisons ranged from low to moderate. The main limitations in the quality of the evidence were risk of bias associated with poor reporting of study methods, and imprecision.In the general population of women undergoing IVF, it is unclear whether CC or Ltz used with or without gonadotropins compared to use of gonadotropins along with gonadotropin-releasing hormone (GnRH) agonists or antagonists resulted in a difference in live birth (RR 0.92, 95% CI 0.66 to 1.27, 4 RCTs, n = 493, I2 = 0%, low-quality evidence) or clinical pregnancy rate (RR 1.00, 95% CI 0.86 to 1.16, 12 RCTs, n = 1998, I2 = 3%, moderate-quality evidence). This means that for a typical clinic with 23% LBR using a GnRH agonist regimen, switching to CC or Ltz protocols would be expected to result in LBRs between 15% and 30%. Clomiphene citrate or Ltz protocols were associated with a reduction in the incidence of OHSS (Peto OR 0.21, 95% CI 0.11 to 0.41, 5 RCTs, n = 1067, I2 = 0%, low-quality evidence). This means that for a typical clinic with 6% prevalence of OHSS associated with a GnRH regimen, switching to CC or Ltz protocols would be expected to reduce the incidence to between 0.5% and 2.5%. We found evidence of an increase in cycle cancellation rate with the CC protocol compared to gonadotropins in GnRH protocols (RR 1.87, 95% CI 1.43 to 2.45, 9 RCTs, n = 1784, I2 = 61%, low-quality evidence). There was moderate quality evidence of a decrease in the mean number of ampoules used,) and mean number of oocytes collected with CC with or without gonadotropins compared to the gonadotropins in GnRH agonist protocols, though data were too heterogeneous to pool.Similarly, in the poor-responder population, it is unclear whether there was any difference in rates of live birth (RR 1.16, 95% CI 0.49 to 2.79, 2 RCTs, n = 357, I2 = 38%, low-quality evidence) or clinical pregnancy (RR 0.85, 95% CI 0.64 to 1.12, 8 RCTs, n = 1462, I2 = 0%, low-quality evidence) following CC or Ltz with or without gonadotropin versus gonadotropin and GnRH protocol. This means that for a typical clinic with a 5% LBR in the poor responders using a GnRH protocol, switching to CC or Ltz protocols would be expected to yield LBRs between 2% to 14%. There was low quality evidence that the CC or Ltz protocols were associated with an increase in the cycle cancellation rate (RR 1.46, 95% CI 1.18 to 1.81, 10 RCTs, n = 1601, I2 = 64%) and moderate quality evidence of a decrease in the mean number of gonadotropin ampoules used and the mean number of oocytes collected, though data were too heterogeneous to pool. The adverse effects of these protocols were poorly reported. In addition, data on foetal abnormalities following use of CC or Ltz protocols are lacking.

Authors' conclusions: We found no conclusive evidence indicating that clomiphene citrate or letrozole with or without gonadotropins differed from gonadotropins in GnRH agonist or antagonist protocols with respect to their effects on live-birth or pregnancy rates, either in the general population of women undergoing IVF treatment or in women who were poor responders. Use of clomiphene or letrozole led to a reduction in the amount of gonadotropins required and the incidence of OHSS. However, use of clomiphene citrate or letrozole may be associated with a significant increase in the incidence of cycle cancellations, as well as reductions in the mean number of oocytes retrieved in both the general IVF population and the poor responders. Larger, high-quality randomized trials are needed to reach a firm conclusion before they are adopted into routine clinical practice.

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Conflict of interest statement

MSK: no conflicts of interest to declare.

AM: no conflicts of interest to declare.

SB: no conflicts of interest to declare.

KYL: no conflicts of interest to declare.

AG: no conflicts of interest to declare.

Figures

1
1
Study flow diagram.
2
2
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
3
3
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
4
4
Forest plot of comparison: 1 Clomiphene citrate or letrozole with or without gonadotropins in conjunction with or without midcycle antagonist versus gonadotropins (with GnRH agonists or midcycle antagonist) in IVF and ICSI cycles in general population, outcome: 1.1 Live birth.
5
5
Forest plot of comparison: 1 Clomiphene citrate or letrozole with or without gonadotropins in conjunction with or without midcycle antagonist versus gonadotropins (with GnRH agonists or midcycle antagonist) in IVF and ICSI cycles in general population, outcome: 1.2 Ovarian hyperstimulation syndrome.
6
6
Funnel plot of comparison: 1 Clomiphene citrate or letrozole with gonadotropins in conjunction with or without midcycle antagonist versus gonadotropins with GnRH protocols in IVF and ICSI cycles in general population, outcome: 1.4 Clinical pregnancy rate.
7
7
Forest plot of comparison: 2 Clomiphene citrate or letrozole with or without gonadotropins in conjunction with or without midcycle antagonist versus gonadotropins (with GnRH agonist or midcycle antagonist) in IVF and ICSI cycles in poor responders, outcome: 2.1 Live birth.
1.1
1.1. Analysis
Comparison 1 Clomiphene citrate or letrozole with or without gonadotropins in conjunction with or without midcycle antagonist versus gonadotropins (with GnRH agonists or midcycle antagonist) in IVF and ICSI cycles in general population, Outcome 1 Live birth.
1.2
1.2. Analysis
Comparison 1 Clomiphene citrate or letrozole with or without gonadotropins in conjunction with or without midcycle antagonist versus gonadotropins (with GnRH agonists or midcycle antagonist) in IVF and ICSI cycles in general population, Outcome 2 Ovarian hyperstimulation syndrome.
1.3
1.3. Analysis
Comparison 1 Clomiphene citrate or letrozole with or without gonadotropins in conjunction with or without midcycle antagonist versus gonadotropins (with GnRH agonists or midcycle antagonist) in IVF and ICSI cycles in general population, Outcome 3 Ongoing pregnancy rate.
1.4
1.4. Analysis
Comparison 1 Clomiphene citrate or letrozole with or without gonadotropins in conjunction with or without midcycle antagonist versus gonadotropins (with GnRH agonists or midcycle antagonist) in IVF and ICSI cycles in general population, Outcome 4 Clinical pregnancy rate.
1.5
1.5. Analysis
Comparison 1 Clomiphene citrate or letrozole with or without gonadotropins in conjunction with or without midcycle antagonist versus gonadotropins (with GnRH agonists or midcycle antagonist) in IVF and ICSI cycles in general population, Outcome 5 Cancellation rate.
1.6
1.6. Analysis
Comparison 1 Clomiphene citrate or letrozole with or without gonadotropins in conjunction with or without midcycle antagonist versus gonadotropins (with GnRH agonists or midcycle antagonist) in IVF and ICSI cycles in general population, Outcome 6 Mean number of ampoules used.
1.7
1.7. Analysis
Comparison 1 Clomiphene citrate or letrozole with or without gonadotropins in conjunction with or without midcycle antagonist versus gonadotropins (with GnRH agonists or midcycle antagonist) in IVF and ICSI cycles in general population, Outcome 7 Mean number of oocytes retrieved.
1.8
1.8. Analysis
Comparison 1 Clomiphene citrate or letrozole with or without gonadotropins in conjunction with or without midcycle antagonist versus gonadotropins (with GnRH agonists or midcycle antagonist) in IVF and ICSI cycles in general population, Outcome 8 Multiple pregnancy rate.
1.9
1.9. Analysis
Comparison 1 Clomiphene citrate or letrozole with or without gonadotropins in conjunction with or without midcycle antagonist versus gonadotropins (with GnRH agonists or midcycle antagonist) in IVF and ICSI cycles in general population, Outcome 9 Rate of miscarriage.
1.10
1.10. Analysis
Comparison 1 Clomiphene citrate or letrozole with or without gonadotropins in conjunction with or without midcycle antagonist versus gonadotropins (with GnRH agonists or midcycle antagonist) in IVF and ICSI cycles in general population, Outcome 10 Rate of ectopic pregnancy.
1.11
1.11. Analysis
Comparison 1 Clomiphene citrate or letrozole with or without gonadotropins in conjunction with or without midcycle antagonist versus gonadotropins (with GnRH agonists or midcycle antagonist) in IVF and ICSI cycles in general population, Outcome 11 Rate of foetal abnormalities.
2.1
2.1. Analysis
Comparison 2 Clomiphene citrate or letrozole with or without gonadotropins in conjunction with or without midcycle antagonist versus gonadotropins (with GnRH agonist or midcycle antagonist) in IVF and ICSI cycles in poor responders, Outcome 1 Live birth.
2.2
2.2. Analysis
Comparison 2 Clomiphene citrate or letrozole with or without gonadotropins in conjunction with or without midcycle antagonist versus gonadotropins (with GnRH agonist or midcycle antagonist) in IVF and ICSI cycles in poor responders, Outcome 2 Ongoing pregnancy rate.
2.3
2.3. Analysis
Comparison 2 Clomiphene citrate or letrozole with or without gonadotropins in conjunction with or without midcycle antagonist versus gonadotropins (with GnRH agonist or midcycle antagonist) in IVF and ICSI cycles in poor responders, Outcome 3 Clinical pregnancy rate.
2.4
2.4. Analysis
Comparison 2 Clomiphene citrate or letrozole with or without gonadotropins in conjunction with or without midcycle antagonist versus gonadotropins (with GnRH agonist or midcycle antagonist) in IVF and ICSI cycles in poor responders, Outcome 4 Cancellation rate.
2.5
2.5. Analysis
Comparison 2 Clomiphene citrate or letrozole with or without gonadotropins in conjunction with or without midcycle antagonist versus gonadotropins (with GnRH agonist or midcycle antagonist) in IVF and ICSI cycles in poor responders, Outcome 5 Mean number of ampoules used.
2.6
2.6. Analysis
Comparison 2 Clomiphene citrate or letrozole with or without gonadotropins in conjunction with or without midcycle antagonist versus gonadotropins (with GnRH agonist or midcycle antagonist) in IVF and ICSI cycles in poor responders, Outcome 6 Mean number of oocytes retrieved..
2.7
2.7. Analysis
Comparison 2 Clomiphene citrate or letrozole with or without gonadotropins in conjunction with or without midcycle antagonist versus gonadotropins (with GnRH agonist or midcycle antagonist) in IVF and ICSI cycles in poor responders, Outcome 7 Multiple pregnancy rate.
2.8
2.8. Analysis
Comparison 2 Clomiphene citrate or letrozole with or without gonadotropins in conjunction with or without midcycle antagonist versus gonadotropins (with GnRH agonist or midcycle antagonist) in IVF and ICSI cycles in poor responders, Outcome 8 Rate of miscarriage.
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References to other published versions of this review

Gibreel 2012
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