A Prospective Randomised Comparative Clinical Trial Study of Luteal PhaseLetrozole versus Ganirelix Acetate Administration to Prevent Severity of Early Onset OHSS in ARTs.

Choudhary RA, Vora PH, Darade KK, Pandey S, Ganla KN

International journal of fertility & sterility16 Oct 2021Cited by 7 (Europe PMC)

PMID34913294PMCIDPMC8530210DOI10.22074/ijfs.2021.139562.1042PepBankPUB-34913294

Summary

BackgroundOvarian hyperstimulation syndrome (OHSS) is the most notable complication in ovulation induction for assisted reproductive techniques (ARTs) like in vitro fertilization (IVF) and intracytoplasmic sperm injection (ICSI). Hence, we decided to evaluate the effect of the aromatase inhibitor, letrozole, versus gonadotrophin-releasing hormone (GnRH)-antagonist (ganirelix acetate) on prevention of severity of OHSS and reduction in serum estradiol (E2) levels when administered during the luteal phase after oocyte retrieval in IVF/ICSI cycles.Materials and methodsIn this prospective single-centred, randomized, parallel-arm study, 122 patients were randomized to receive oral letrozole (n=61, 2.5 mg twice daily) or ganirelix acetate (n=61, 0.25 mg subcutaneously daily) from the day of egg retrieval for the next 7 days. Incidence and severity of early OHSS were the primary endpoints assessed by the signs, symptoms, and laboratory findings of OHSS (e.g., serum E2 levels). The secondary endpoints were patient satisfaction and the additional cost of therapy to prevent the severity of OHSS.ResultsLetrozole group had lower incidence of OHSS (13.1%) compared to 19.6% in ganirelix acetate group (P=0.32). Serum E2 levels on post-pick up days 5 and 7 were significantly lower in the letrozole group when compared to the ganirelix acetate group (P=0.001). The majority of the patients in both groups had no major complications. No significant difference was found between the study groups with respect to the incidence of OHSS (P=0.33). The additional cost per IVF cycle for prevention of severity of early-onset OHSS in the letrozole group was 5.32 USD compared to 267.26 USD in the ganirelix acetate group, which was almost fifty times costlier.ConclusionLetrozole and ganirelix acetate have the same efficiency for the overall prevention of OHSS, whereas letrozole was more effective in preventing moderate OHSS. Letrozole had better patient satisfaction and is cheaper compared to GnRH antagonists (Registration number: CTRI/2020/10/028674).

CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study5

5 results from studies that gave the peptide. 5 results from people.

01HumanRandomized controlled trialEfficacy outcome
In IVF/ICSI patients, OHSS incidence was 19.6% with ganirelix versus 13.1% with letrozole, without a significant difference (P=0.32; also reported P=0.33).
In plain wordsIn IVF/ICSI patients, OHSS incidence did not differ significantly between ganirelix and letrozole.
Peptide
Ganirelix
Outcome
No significant changeOHSS incidence
Study
n = 122
Comparator
Letrozole
Analysis
Primary
Outcome group
Adverse events · Reproductive and sexual health
Studied dose
0.25 mg daily · subcutaneous · 7 daysAs given in this study (human).
Measurements
OHSS incidence
13.1%
letrozole group
OHSS incidence
19.6%
ganirelix acetate group
Source sentences
Summary
Letrozole group had lower incidence of OHSS (13.1%) compared to 19.6% in ganirelix acetate group (P=0.32).
2 context sentences(design, population, supporting numbers)
Summary · context
No significant difference was found between the study groups with respect to the incidence of OHSS (P=0.33).
Summary · context
In this prospective single-centred, randomized, parallel-arm study, 122 patients were randomized to receive oral letrozole (n=61, 2.5 mg twice daily) or ganirelix acetate (n=61, 0.25 mg subcutaneously daily) from the day of egg retrieval for the next 7 days.
Show in the study text Report a problemFND-3491329401
02HumanRandomized controlled trialEfficacy outcome
In IVF/ICSI patients, serum E2 on post-pick up day 5 was higher with ganirelix than letrozole (P=0.001).
In plain wordsIn IVF/ICSI patients, estradiol was higher with ganirelix than letrozole on day 5 after egg retrieval.
Peptide
Ganirelix
Outcome
IncreaseSerum estradiol on day 5
Study
n = 122
Comparator
Letrozole
Analysis
Primary
Outcome group
Sex hormones and fertility · Reproductive and sexual health
Studied dose
0.25 mg daily · subcutaneous · 7 daysAs given in this study (human).
Source sentences
Summary
Serum E2 levels on post-pick up days 5 and 7 were significantly lower in the letrozole group when compared to the ganirelix acetate group (P=0.001).
1 context sentence(design, population, supporting numbers)
Summary · context
In this prospective single-centred, randomized, parallel-arm study, 122 patients were randomized to receive oral letrozole (n=61, 2.5 mg twice daily) or ganirelix acetate (n=61, 0.25 mg subcutaneously daily) from the day of egg retrieval for the next 7 days.
Show in the study text Report a problemFND-3491329402
03HumanRandomized controlled trialEfficacy outcome
In IVF/ICSI patients, serum E2 on post-pick up day 7 was higher with ganirelix than letrozole (P=0.001).
In plain wordsIn IVF/ICSI patients, estradiol was higher with ganirelix than letrozole on day 7 after egg retrieval.
Peptide
Ganirelix
Outcome
IncreaseSerum estradiol on day 7
Study
n = 122
Comparator
Letrozole
Analysis
Primary
Outcome group
Sex hormones and fertility · Reproductive and sexual health
Studied dose
0.25 mg daily · subcutaneous · 7 daysAs given in this study (human).
Source sentences
Summary
Serum E2 levels on post-pick up days 5 and 7 were significantly lower in the letrozole group when compared to the ganirelix acetate group (P=0.001).
1 context sentence(design, population, supporting numbers)
Summary · context
In this prospective single-centred, randomized, parallel-arm study, 122 patients were randomized to receive oral letrozole (n=61, 2.5 mg twice daily) or ganirelix acetate (n=61, 0.25 mg subcutaneously daily) from the day of egg retrieval for the next 7 days.
Show in the study text Report a problemFND-3491329403
04HumanRandomized controlled trialOther
In IVF/ICSI patients, additional prevention cost was 267.26 USD per cycle with ganirelix versus 5.32 USD with letrozole, almost fifty times higher.
In plain wordsIn IVF/ICSI patients, ganirelix cost more than letrozole for preventing early OHSS severity.
Peptide
Ganirelix
Outcome
IncreaseAdditional cost per IVF cycle
Study
n: not reported in source
Comparator
Letrozole
Analysis
Secondary
Outcome group
Healthcare costs and utilization · Reproductive and sexual health
Studied dose
0.25 mg daily · subcutaneous · 7 daysAs given in this study (human).
Measurements
Additional cost per IVF cycle
267.26 USD
ganirelix acetate group
Additional cost per IVF cycle
5.32 USD
letrozole group
Source sentences
Summary
The additional cost per IVF cycle for prevention of severity of early-onset OHSS in the letrozole group was 5.32 USD compared to 267.26 USD in the ganirelix acetate group, which was almost fifty times costlier.
1 context sentence(design, population, supporting numbers)
Summary · context
In this prospective single-centred, randomized, parallel-arm study, 122 patients were randomized to receive oral letrozole (n=61, 2.5 mg twice daily) or ganirelix acetate (n=61, 0.25 mg subcutaneously daily) from the day of egg retrieval for the next 7 days.
Show in the study text Report a problemFND-3491329405
05HumanRandomized controlled trialSafety outcome
In IVF/ICSI patients, most patients in both ganirelix and letrozole groups had no major complications.
In plain wordsIn IVF/ICSI patients, most patients in both ganirelix and letrozole groups had no major complications.
Peptide
Ganirelix
Outcome
Not applicableMajor complications
Study
n = 122
Comparator
Letrozole
Outcome group
Adverse events · Reproductive and sexual health
Studied dose
0.25 mg daily · subcutaneous · 7 daysAs given in this study (human).
Source sentences
Summary
The majority of the patients in both groups had no major complications.
1 context sentence(design, population, supporting numbers)
Summary · context
In this prospective single-centred, randomized, parallel-arm study, 122 patients were randomized to receive oral letrozole (n=61, 2.5 mg twice daily) or ganirelix acetate (n=61, 0.25 mg subcutaneously daily) from the day of egg retrieval for the next 7 days.
Show in the study text Report a problemFND-3491329404

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Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 2Current
28 Oct 2026, 02:03 UTC
Study results updated
Version 1
27 Oct 2026, 16:35 UTC
First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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