NCT07653282

Brief Summary

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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
122

participants targeted

Target at P75+ for phase_1

Timeline
24mo left

Started Aug 2026

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 12, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 17, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2026

Expected
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2028

Last Updated

June 17, 2026

Status Verified

June 1, 2026

Enrollment Period

1 year

First QC Date

June 12, 2026

Last Update Submit

June 12, 2026

Conditions

GnRH Agonist

Keywords

gnrh agonist

Outcome Measures

Primary Outcomes (1)

  • Clinical pregnancy rate

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

    basline

Secondary Outcomes (5)

  • Implantation rate

    basline

  • Ongoing pregnancy rate

    basline

  • Early miscarriage rate

    basline

  • . Live birth rate per ET

    basline

  • Side effects

    basline

Study Arms (2)

Standard HRT protocol only. No additional injection

NO INTERVENTION

arm will not recieve any injection

Standard HRT protocol + Triptorelin 0.1mg subcutaneous injection, administered once 30-60 minutes af

EXPERIMENTAL

arm will recieve injection

Drug: GnRH agonist

Interventions

GnRH agonistDRUG

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

Also known as: triptofem0.1 amp
Standard HRT protocol + Triptorelin 0.1mg subcutaneous injection, administered once 30-60 minutes af

Eligibility Criteria

Age20 Years - 39 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailswomen only
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \. 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

You may not qualify if:

  • \. 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University

Asyut, Muslum, Egypt

Location

Related Publications (3)

  • Liu Y, Huang K, Chen C, Wen L, Lei M, Guo Y, Tang B. Effect of luteal-phase GnRH agonist on frozen-thawed embryo transfer during artificial cycles: a randomised clinical pilot study. Front Endocrinol (Lausanne). 2023 Jun 9;14:1098576. doi: 10.3389/fendo.2023.1098576. eCollection 2023.

    PMID: 37361538RESULT

  • Li S, Li Y. Administration of a GnRH agonist during the luteal phase frozen-thawed embryo transfer cycles: a meta-analysis. Gynecol Endocrinol. 2018 Nov;34(11):920-924. doi: 10.1080/09513590.2018.1480714. Epub 2018 Jul 11.

    PMID: 29996682RESULT

  • Chang WS, Lin PH, Li CJ, Chern CU, Chen YC, Lin LT, Tsui KH. Additional single dose GnRH agonist during luteal phase support may improve live birth rate in GnRHa-HRT frozen-thawed embryo transfer cycle: a retrospective cohort study. BMC Pregnancy Childbirth. 2023 Mar 14;23(1):174. doi: 10.1186/s12884-023-05491-y.

    PMID: 36918869RESULT

Related Links

MeSH Terms

Interventions

Gonadotropin-Releasing Hormone

Intervention Hierarchy (Ancestors)

Pituitary Hormone-Releasing HormonesHypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteins

Central Study Contacts

Raafat Ahmed, master

CONTACT

+20 01029975352raafatahmed4000@gmail.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
residant doctor

Study Record Dates

First Submitted

June 12, 2026

First Posted

June 17, 2026

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

August 1, 2028

Last Updated

June 17, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Available IPD Datasets

Study Protocol Access

Locations

EG(1)