GnRH Antagonist Pre-treatment for the Prevention of Asynchronous Follicular Growth

NCT05071339 | Unknown Phase 4 FDA Drug

• 1 other identifier: 0013-21-ASF
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

In the study the investigators would like to examine the effect of GnRH antagonist administration at the beginning of the follicular phase in patients presenting with high baseline estradiol levels of 200 pmol/L or above with a leading follicle of 11-13 mm. In the unit's practice, patients presenting for cycle initiation with a leading follicle \> 10 in the presence of E2 \> 200 pmol/L (54 pg/ml) are deferred and receive a priming antagonist protocol in their sequential cycle. The aim of this intervention is to suppress FSH levels at the beginning of the cycle thus preventing estradiol secretion of the leading follicle. This may contribute to better synchronization of the remaining antral follicles cohort and allow for a better cycle outcome instead of cancellation or one-month postponement. As previous studies using GnRH antagonist pre-treatment prior to GT initiation for synchronization purposes demonstrated positive results (including different patient population) , no deleterious effects are expected.

Conditions

IVF

Outcome Measures

Primary Outcomes (1)

• Synchronization of follicles

  Ratio of number of large (\>15 mm) to small (\<10-15mm) follicles.

  2 year

Secondary Outcomes (3)

• Number of mature oocytes that originate from the leading follicles

  2 year

• Ratio of mature oocytes out of number of follicles

  2 year

• Number of oocytes compared to a previous cycle

  2 years

Study Arms (1)

Participants

EXPERIMENTAL

Patients treated at the IVF unit at Shamir Medical Center planned for an antagonist cycle will undergo blood test and US exam at day 2-3 of their menstrual cycle. Patients will be recruited if a leading follicle 10-13 is shown in the presence of E2 \> 200-350 pmol/L. Patients will start GnRH antagonist injections \[Cetrotide (cetrolix) or Orgalutran (ganirelix) - depending on their primary prescription\] for 3-5 days intervention.

Drug: Ganirelix Acetate, Cetrolix Acetate

Interventions

Ganirelix Acetate, Cetrolix Acetate DRUG

3-6 days of 0.25mg GnRH antagonist starting day 2-3 of the menstrual cycle prior to the administration of the original protocol.

Participants

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Planed antagonist protocol.
• Presentation for cycle initiation with a leading follicle 10-13 in the presence of E2 \> 200 and \<350 pmol/L (54 pg/ml).

You may not qualify if:

• Inability to provide informed consent.
• Oocyte donor

Sponsors & Collaborators

• Assaf-Harofeh Medical Center: lead

Study Sites (1)

Shamir Medical center

Be’er Ya‘aqov, Israel

RECRUITING

MeSH Terms

Interventions

ganirelix

Central Study Contacts

Michal Youngster, MD

CONTACT

+972506430111; michalyo@gmail.com

Ariel Hourvitz, MD

CONTACT

+972526666063; ariel@hourvitz.co.il

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior physician

Study Record Dates

• First Submitted: February 20, 2021
• First Posted: October 8, 2021
• Study Start: April 1, 2021
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2023
• Last Updated: October 8, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)