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NCT Number: NCT07653282

Effect of GnRH Agonist in FET

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

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Key information

Conditions

Age range

20 year–39 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Assiut University

Asyut, Muslum, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GnRH agonist

Drug

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

Other names: triptofem0.1 amp

Primary outcomes

  1. 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

  1. Implantation rate

    Time frame: basline

    Number of gestational sacs / Number of embryos transferred x100

  2. Ongoing pregnancy rate

    Time frame: basline

    Viable pregnancy ≥12 weeks gestation per ET

  3. Early miscarriage rate

    Time frame: basline

    Pregnancy loss <12 weeks after clinical pregnancy diagnosed

  4. . Live birth rate per ET

    Time frame: basline

    . Live birth rate per ET

  5. Side effects

    Time frame: basline

    Injection site reaction, headache, vaginal bleeding

Study contacts

Contact information is provided by the study sponsor or research team.

Raafat Ahmed, master

CONTACT

[email protected]

+20 01029975352

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Collaborators

  • Woman's Health University Hospital, Egypt

Registry information

Official study title

Single Dose of Gonadotropin Releasing Hormone (GnRH)-Agonist as an Adjuvant Luteal Phase Support in Hormone Replacement Therapy (HRT) Frozen Embryo Transfer (FET) Cycles Prospective Comparative Study

Acronym: gnrh agonist

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jun 17, 2026
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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