Current partner codePEPTIDESDE

Effect of GnRH Agonist in FET

Status

Not yet recruiting

Phase

Phase 1 / Phase 2

Enrollment

122

Locations

1

Results

Not posted

Publications

3

Study summary

What the protocol is testing.

To evaluate the impact of single dose GnRH agonist administration as luteal phase support on pregnancy outcomes in frozen ICSI cycle

Full detailed description

Assisted reproductive technologies (ART), particularly intracytoplasmic sperm injection (ICSI) with frozen embryo transfer, have significantly improved the outcomes of infertility treatment over the past decades. Despite these advances, implantation failure and suboptimal pregnancy rates remain important challenges. One of the critical factors influencing the success of embryo implantation is adequate luteal phase support, which ensures proper endometrial receptivity and maintenance of early pregnancy. (1\_3) Progesterone supplementation has long been established as the standard method for luteal phase support in frozen ICSI cycles. It plays a fundamental role in transforming the endometrium into a receptive state suitable for embryo implantation and sustaining early gestation. However, despite its widespread use, pregnancy outcomes are not optimal in all cases, suggesting the need for additional or alternative therapeutic strategies to enhance reproductive success.(1\_3) Recently, gonadotropin-releasing hormone (GnRH) agonists have gained increasing attention as a potential adjunct in luteal phase support protocols. It has been proposed that GnRH agonists may exert beneficial effects through multiple mechanisms, including stimulation of endogenous luteinizing hormone (LH) secretion, improved corpus luteum function, and enhanced progesterone production. Additionally, emerging evidence suggests a possible direct effect on the endometrium and embryo-endometrial interaction, which may further improve implantation potential.(4-7) Despite promising findings from several randomized controlled trials and meta-analyses, the role of GnRH agonists in luteal phase support remains controversial. Some studies have demonstrated improved implantation and clinical pregnancy rates, while others have reported no significant benefit compared to conventional progesterone therapy alone. This inconsistency is particularly evident in frozen ICSI cycles, where hormonal dynamics differ from fresh cycles.Therefore, further well-designed prospective studies are required to clarify the effectiveness of GnRH agonists in luteal phase support and to determine their potential role in improving reproductive outcomes

Interventions

Treatment arms and agents.

DRUG

GnRH agonist

women undergoing frozen ICSI cycles receiving progesterone + GnRH agonist for luteal phase support.

Timeline

From registration to results.

  1. First posted

    Jun 17, 2026

  2. Study start

    Aug 1, 2026

  3. Primary completion

    Aug 1, 2027

  4. Study completion

    Aug 1, 2028

  5. Results posted

    Not reported

  6. Registry updated

    Jun 17, 2026

Outcomes

What the study measures.

Primary outcomes

Clinical pregnancy rate

Time frame · basline

Presence of ≥1 gestational sac with fetal heartbeat on TVS at 6-7 weeks per embryo transfer.

Secondary outcomes

Implantation rate

Time frame · basline

Number of gestational sacs / Number of embryos transferred x100

Ongoing pregnancy rate

Time frame · basline

Viable pregnancy ≥12 weeks gestation per ET

Early miscarriage rate

Time frame · basline

Pregnancy loss \<12 weeks after clinical pregnancy diagnosed

. Live birth rate per ET

Time frame · basline

. Live birth rate per ET

Side effects

Time frame · basline

Injection site reaction, headache, vaginal bleeding

Eligibility

Who can take part.

Minimum age
20 Years
Maximum age
39 Years
Sex
FEMALE
Healthy volunteers
Yes

Inclusion Criteria: * 1\. Age 20-39 years 2. Undergoing HRT-FET cycle 3. ≥1 good quality embryo available , Gardner ≥3BB 4. Endometrial thickness ≥7mm on day of progesterone start 5. BMI 18-35 kg/m² 6. First or second FET cycle 7. Written informed consent Exclusion Criteria: * 1\. History of recurrent implantation failure ≥3 failed embryo transfers 2. Severe endometriosis Stage III-IV by ASRM 3. Uterine anomalies, submucous fibroid, or severe adenomyosis distorting cavity 4. History of recurrent pregnancy loss ≥2 consecutive 5. Contraindication or hypersensitivity to GnRH agonist 6. PGT-A cycles 7. Donor oocyte cycles

Study locations

1 registered sites.

Egypt. Showing up to 24 locations stored in the fast local snapshot.

Assiut University

Asyut, Muslum, Egypt

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Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.