Addition of Gonadotropin Releasing Hormone Agonist to Luteal Phase Support

January 27, 2025 updated by: Alexandria University

Impact of Addition of Gonadotropin Releasing Hormone Agonist to Luteal Phase Support on Antagonist ICSI Cycles

Hormonal milieu during implantation is crucial to embryo-endometrium interaction and to the viability of the conceptus. Alterations in the peri-implantation environment are considered to impair perinatal outcomes in intracytoplasmic sperm injection (ICSI) therapy. GnRH-a is a new and promising modality for LPS. Regimens for using GnRH-a in LPS, including single mid-luteal bolus or the addition of a GnRH-a to progesterone supplementation, have been recently suggested. The aim of this study is to evaluate the impact of addition of mid-luteal single-dose or multiple-dose GnRH agonist to the routine luteal phase support in patients undergoing ICSI cycles using GnRH antagonist protocol.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Hormonal milieu during implantation is crucial to embryo-endometrium interaction and to the viability of the conceptus. There are many protocols of luteal phase support (LPS) in assisted reproductive technology (ART) cycles. GnRH-agonist (GnRH-a) is a new and promising modality for LPS. Regimens for using GnRH-a in LPS, including single mid-luteal bolus or the addition of a GnRH-a to progesterone supplementation, have been recently suggested. If the GnRH-a is administered in the mid-luteal phase, an initial flare-up with increased levels of LH takes 3-4 days before receptor down-regulation kicks in. The increased luteinizing hormone (LH) results in increased support for the corpus luteum (CL), leading to higher output of P4 and providing stronger LPS. In earlier studies, the inadvertent administration of GnRH-a in the mid-luteal phase, did not compromise pregnancy outcomes but rather enhanced implantation rates. Therefore, the use of GnRH-a in LPS was investigated and found to enhance clinical outcomes after GnRH-a and GnRH antagonist- treated ovarian stimulation cycles, as well as, in recipients of donated oocytes. Several studies since then investigated the role of GnRHa for LPS, found that luteal support with GnRH-a could be used as the first choice in patients at high risk for ovarian hyperstimulation syndrome (OHSS), or even as the sole source of LPS in a GnRH-a-triggered antagonist ovarian stimulation cycle. Although many trials have showed substantial efficacy of GnRH-a addition for luteal support on pregnancy outcomes in women undergoing IVF/ICSI, others, found no benefit of its addition to the standard LPS. A meta-analysis concluded that there is benefit, however, this evidence is of very low quality. The aim of this study is to evaluate the impact of addition of mid-luteal single-dose or multiple-dose GnRH agonist to the routine luteal phase support in patients undergoing ICSI cycles using GnRH antagonist protocol.

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Alexandria, Egypt, 21526
        • Alexandria University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 38 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patient age ≤ 38 years.
  2. BMI ≤ 30.
  3. Basal follicle stimulating hormone (FSH) level ≤ 10 IU/L.
  4. Anti-Müllerian hormone (AMH): ≤ 5 ng/ml.

Exclusion Criteria:

  1. Endometriosis.
  2. Polycystic ovarian syndrome (PCOS).
  3. Uterine pathology or anomaly.
  4. Evidence of hydrosalpinx by hysterosalpingography or ultrasound.
  5. Comorbidities: Diabetes mellitus, hypertension, immune diseases.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1
Will receive routine LPS and additional single GnRH-a bolus, triptorelin 0.1 mg subcutaneous injection on the 6th day after oocyte retrieval.
Drug: gonadotropin releasing hormone-agonist
subcutaneous injection
Other Names:
  • triptorelin 0.1 mg
Drug: Progesterone
vaginal suppositories (400 mg twice daily) starting on the day after oocyte retrieval and will be continued till pregnancy assessed by serum β-HCG 15 days after ICSI, and if pregnant, for 10 weeks of gestation.
Other Names:
  • cyclogest
Experimental: Group 2
Will receive routine LPS and additional multiple mid-luteal GnRH-a, triptorelin 0.1 mg subcutaneous injection on the 5th, 7th and 9th days after oocyte retrieval.
Drug: gonadotropin releasing hormone-agonist
subcutaneous injection
Other Names:
  • triptorelin 0.1 mg
Drug: Progesterone
vaginal suppositories (400 mg twice daily) starting on the day after oocyte retrieval and will be continued till pregnancy assessed by serum β-HCG 15 days after ICSI, and if pregnant, for 10 weeks of gestation.
Other Names:
  • cyclogest
Active Comparator: Group 3 (Control)
Will receive the routine LPS without GnRH-a
Drug: Progesterone
vaginal suppositories (400 mg twice daily) starting on the day after oocyte retrieval and will be continued till pregnancy assessed by serum β-HCG 15 days after ICSI, and if pregnant, for 10 weeks of gestation.
Other Names:
  • cyclogest

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical pregnancy rate
Time Frame: 2 weeks after positive pregnancy test
Calculated as the number of clinical pregnancies (Presence of an intrauterine gestational sac with embryonic cardiac activity observed by vaginal ultrasound) divided by the number of embryo transfer procedures.
2 weeks after positive pregnancy test

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implantation rate
Time Frame: 2 weeks after positive pregnancy test
the ratio of the number of gestational sacs detected by sonography to the total number of embryos transferred.
2 weeks after positive pregnancy test
Multiple pregnancy rate
Time Frame: 8 weeks of gestation
The percentage of pregnancies with more than one fetus
8 weeks of gestation
Serum β-human chorionic gonadotropin (β-HCG) concentration
Time Frame: 15 days after ICSI
In milli-International unit/ml on day 15 after ICSI
15 days after ICSI

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alexandria University

Investigators

  • Principal Investigator: Mervat Sheikh El-arab, PhD, Alexandria Univsersity
  • Study Director: Ahmed Abdel Aziz, PhD, Alexandria Univsersity

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 17, 2022

Primary Completion (Actual)

October 27, 2023

Study Completion (Actual)

January 18, 2024

Study Registration Dates

First Submitted

March 10, 2022

First Submitted That Met QC Criteria

March 10, 2022

First Posted (Actual)

March 18, 2022

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 27, 2025

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0201599

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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