Follicular Volume at the Time of Final Oocyte Maturation in Poor Responders, and Its Correlation With Oocyte Maturity

April 7, 2025 updated by: ART Fertility Clinics LLC

Women with a severely diminished ovarian reserve and monofollicular growth are at a higher risk of premature ovulation as well as poor quality oocytes. Our group showed previously that women with severely diminished ovarian reserve benefit from receiving the final oocyte maturation at smaller follicle sizes in terms of reducing the risk of premature ovulation and finding mature oocytes even out of small size follicles.

Adding the measurement of the follicular volume at the time of final oocyte maturation might provide more information on the proper timing of trigger administration compared to the follicular size alone, hormonal profile as well as previous stimulation attempts. Setting a cutoff value of follicular volume for trigger might help to avoid premature ovulation and possibly increase the chances of ending up with a euploid embryo.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

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

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Patients in ART Fertility Clinics who will undergo ovarian stimulation

  • Reproductive age group: 18 -48
  • undergoing ovarian stimulation for oocyte vetrification
  • undergoing IVF/ ICSI with PGT-A / PGT-M / PGT- Sr
  • less than or equal to 3 AFC on initiation of stimulation
  • follicular phase stimulation

Description

Inclusion Criteria:

  • Reproductive age group: 18 -48
  • undergoing ovarian stimulation for oocyte vetrification
  • undergoing IVF/ ICSI with PGT-A / PGT-M / PGT- Sr
  • less than or equal to 3 AFC on initiation of stimulation
  • follicular phase stimulation

Exclusion Criteria:

  • surgically retrieved sperm

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
The study population is the infertile patients seeking IVF treatment in ART fertility clinics of Abu
Recruited patients will be stimulated in a antagonist protocol with the use of Pergoveris as gonadotropin with a starting dose of 450 IU. The antagonist will be started on day 5 of the stimulation. Patients will be triggered according to clinical standard protocol for poor ovarian reserve patients when the leading follicle reaches 15 mm (2). The only additional measure will be the measurement of the follicle volumes on the day of trigger and before oocyte pick up procedure. This will be performed at the same time as the pre oocyte pick up ultrasound prior to the patient admission to the recovery room for preparation. The ultrasound that will be used already has a pre build program that calculates the follicular volume automatically and hence not extending the ultrasound time. Oocyte pickup will be performed the same way as per the SOP of the clinic for the patients who have less than 7 follicles on the day of the ovum pickup i.e. each follicle will be punctured, aspirated and then flu
Other: transvaginal Ultrasound
The only additional measure will be the measurement of the follicle volumes on the day of trigger and before oocyte pick up procedure. This will be performed at the same time as the pre Oocyte pick up ultrasound prior to the patient admission to the recovery room for preparation. The ultrasound that will be used already has a pre build program that calculates the follicular volume automatically and hence not extending the ultrasound time.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the investigators will see the corellation between the follicular volume at the time of trigger with the oocyte maturity in patients with less than four follicles of a follicle size of at least 11 mm .
Time Frame: 1 year
The objective of this study is to evaluate the relationship between follicular volume at the time of trigger and oocyte maturity in patients undergoing assisted reproductive techniques, specifically those with fewer than four follicles of at least 11 mm in size. This study aims to determine whether follicular volume just before trigger is a significant predictor of oocyte maturation. By focusing on this specific patient group, the study seeks to provide insights that could inform treatment strategies and improve outcomes in assisted reproductive technology.
1 year

Collaborators and Investigators

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

Sponsor

ART Fertility Clinics LLC

Investigators

  • Study Director: Barbara Lawrenz, PhD, ART Fertility Clinics LLC

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 27, 2025

Primary Completion (Estimated)

November 30, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

February 17, 2025

First Submitted That Met QC Criteria

February 17, 2025

First Posted (Actual)

February 21, 2025

Study Record Updates

Last Update Posted (Actual)

April 9, 2025

Last Update Submitted That Met QC Criteria

April 7, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • 2408-ABU-013-AS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

on request

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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