GnRH Agonist for Luteal Phase Support.

NCT ID: NCT05484193

Last Updated: 2022-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-08

Study Completion Date

2023-01-01

Brief Summary

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Objective To assess the the efficacy of luteal support with GnRH agonist in patients undergoing IVF in antagonist-based hcg triggered cycles compared with standard luteal support with progesterone.

Design prospective randomized controled study Subjects Patients who underwent antagonist-based cycles performed in the "Shaare Zedek Medical Center" IVF clinic between 2020 and 2022 Intervention Intranasal GnRH-agonist or vaginal Progesterone for luteal support.

Main outcome measures Pregnancy and clinical pregnancy rates, ohss.

The study cohort included 150 patients who underwent 164 cycles. A total of 127 cycles were included. Of them, 64 were treated with GnRH-a and 63 with progesterone.

Hypothesis: This RCT suggests that GnRH-a for luteal phase support is associated with a higher positive β-hCG pregnancy rate and clinical pregnancy rate, compared with standard progesterone support in an antagonist-based protocol triggered with hCG, while maintaining a similar safety profile.

Detailed Description

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Conditions

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Use of GnRH Agonist Alone for Luteal Phase Support in Fresh IVF Cycles

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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GnRH-agonist group

In the GnRH-a group, LPS was initiated on the evening after the OPU, using Nafareline (Synarel nasal spray 200mg used once), followed by twice daily (total 400mg/day) until the day of serum β-hCG pregnancy test, and then stopped, regardless of the test results

Group Type EXPERIMENTAL

GnRH agonist

Intervention Type DRUG

GnRH agonist alone for luteal phase support in fresh IVF embryo transfer cycles

Progesterone group

In the progesterone group, LPS was initiated on the morning after OPU, using micronized progesterone ( PV Utrogestan 300mg, 3 times daily), until serum β-hCG pregnancy tests results were available. If a β-hCG pregnancy was confirmed, LPS was continued until the end of the 8th gestational week

Group Type ACTIVE_COMPARATOR

Progesterone

Intervention Type DRUG

vaginal progesterone for luteal phase support

Interventions

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GnRH agonist

GnRH agonist alone for luteal phase support in fresh IVF embryo transfer cycles

Intervention Type DRUG

Progesterone

vaginal progesterone for luteal phase support

Intervention Type DRUG

Other Intervention Names

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Synarel Utrogestan

Eligibility Criteria

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Inclusion Criteria

\-

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Shaare Zedek Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Shaare Zedek medical Center

Jerusalem, , Israel

Site Status

Countries

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Israel

References

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Buhbut E, Nabulsi R, Avigdor G, Ben-Ami I. Comparison of pregnancy rates in antagonist cycles after luteal support with GnRH-agonist versus progesterone: prospective randomized study. Arch Gynecol Obstet. 2023 Jul;308(1):255-263. doi: 10.1007/s00404-023-07017-5. Epub 2023 Apr 25.

Reference Type DERIVED
PMID: 37186265 (View on PubMed)

Other Identifiers

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Synarel fresh LPS

Identifier Type: -

Identifier Source: org_study_id

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