Follicle Size and Oocyte Development (AMJH)

June 23, 2022 updated by: Dr. Aya Mohr-Sasson, Sheba Medical Center

The Effect of Triggering on the Quantitative Assessment of Follicle Size on Oocyte Development

Studies have shown that the follicles greater in diameter was most likely to have a mature oocyte that was capable of fertilization and best suited for development into a high-quality embryo. Smaller follicles showed lower rates ( 60%).

Lately new triggering protocols have emerged aiming to improve the proportion of mature oocytes at the time of retrieval. The aim of this study is to learn the effects of the dual triggering compared to the standard hCG triggering on the oocyte development and quality as a function of the follicle size

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Controlled ovarian hyperstimulation is critical to assisted reproduction because it increases the number of oocytes undergoing development. The medications, designed to override the selection of a single dominant follicle, drive multiple antral follicles into the growth phase. These follicles grow at different rates, and management is guided by their size rather than their competence. Human chorionic gonadotropin (hCG) is usually used as a surrogate LH surge to induce luteinization of the granulosa cells, final oocyte maturation and resumption of meiosis. This treatment is therefore based on an assumption that follicular size predicts the developmental competence of the oocyte. The outcome, is that only a portion of the oocytes will be competent for fertilization and development into viable embryos.

Studies have shown that the follicles greater in diameter was most likely to have a mature oocyte that was capable of fertilization and best suited for development into a high-quality embryo. Smaller follicles showed lower rates ( 60%).

Lately new triggering protocols have emerged aiming to improve the proportion of mature oocytes at the time of retrieval. Following the observations demonstrating comparable or even better oocyte\embryos quality following GnRHa, compared to hCG trigger, and the different effects of LH and hCG on the downstream signaling of the LH receptor, GnRHa is now offered concomitant to the standard hCG trigger dose to improve oocyte/embryo yield and quality. To the best of our knowledge, no studies have been done comparing the effect of the dual triggering on the amount of larger follicles per cycle and its effect on oocyte maturation.

The aim of this study is to learn the effects of the dual triggering compared to the standard hCG triggering on the oocyte development and quality as a function of the follicle size

Material and Methods A prospective cohort study including all women on antagonist protocol for controlled ovarian hyper stimulation with triggering using Ovitrelle ( hCG 250 mcg) or dual triggering - Ovitrelle ( Hcg 250 mcg) + Decapeptyl ( GnRH Agonist 0.1 mg*2 ).

As practiced at the IVF clinic, individuals will be monitored with transvaginal ultrasound and blood samples for hormonal profile ( including Estradiol, Progesteron, FSH). The decision to administer hCG or Dual triggering will be based on physician judgment, and the timing will be based on the lead follicular cohort, usually with at least two follicles measuring 18 mm for maximal diameter. A transvaginal, ultrasound-guided follicular aspiration will be conducted 36 hours after triggering administration. At retrieval, each follicle will be measured before aspiration. Follicles will be divided into five arbitrary follicular groups according to their maximal dimensional size: >18 mm, 16 to 18 mm, 13 to 15 mm, 10 to 12 mm, and <10 mm. Following identification, the follicles will be aspirated. Microscopic examination of the follicular aspirates will be performed by the embryologist. Once the oocytes will be identified, they will be collected and organized according to follicle size. Oocytes will be fertilized using conventional insemination or intracytoplasmic sperm injection (ICSI) . Each embryo will be cultured and evaluated after 72 hours.

Day-3 embryo grading, based on cellular cleavage and fragmentation, will be recorded separately. Fragmentation will be scored by the degree of fragmentation proportional to the whole embryo volume: 1, no fragmentation; 2, <10%; 3, 10% to 25%; 4, 25% to 50%; 5, >50%. The information for each oocyte, starting from the follicular size, will be followed through all laboratory procedures including insemination, oocyte stripping for ICSI, ICSI, pronuclear assessment, embryo culture, and embryo transfer.

Data will be collected from the medical file of each patient.

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

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

  • Israel
      • Ramat Gan, Israel
        • Sheba Medical Center

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

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Age- 18-45
  2. Antagonist protocol
  3. Triggering: A- with Ovitrelle ( HCG) 250 mcg B- with dual triggering - Ovitrelle ( HCG) 250 mcg + Decapeptyl ( GnRH Agonist ) 0.1 mg*2

Exclusion Criteria:

  1. Endometriosis
  2. Known mutation of Fragile X

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: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HCG triggering
Ovitrelle ( hCG 250 mcg)
Diagnostic test: Follicle measurment
Follicle will be measured before aspiration
Drug: Ovitrelle ( Hcg 250 mcg)
Drug used for triggering
Experimental: Dual triggering
Ovitrelle ( Hcg 250 mcg) + Decapeptyl ( GnRH Agonist 0.1 mg*2 )
Diagnostic test: Follicle measurment
Follicle will be measured before aspiration
Drug: Ovitrelle ( Hcg 250 mcg)
Drug used for triggering
Drug: Decapeptyl ( GnRH Agonist 0.1 mg*2 )
Drug used for triggering

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oocyte retrieved in each of the follicular size groups
Time Frame: Through study completion, an average of 1 year
Number of oocyte retrieved in each of the follicular groups divided according to the maximal dimensional size
Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Metaphase II oocytes (MII)
Time Frame: Through study completion, an average of 1 year
Oocyte undergone nuclear maturation -Metaphase II oocytes (MII)
Through study completion, an average of 1 year
Fertilization rate
Time Frame: Through study completion, an average of 1 year
Fertilization rate ( 2 pronuclear)
Through study completion, an average of 1 year
Top Quality Embryo
Time Frame: Through study completion, an average of 1 year
Top Quality Embryo - Day-3 embryo with 3-4 cells with of to 15% fragmentation rate
Through study completion, an average of 1 year

Collaborators and Investigators

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

Sponsor

Sheba Medical Center

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)

July 1, 2018

Primary Completion (Actual)

August 1, 2021

Study Completion (Actual)

August 1, 2021

Study Registration Dates

First Submitted

July 4, 2018

First Submitted That Met QC Criteria

September 4, 2018

First Posted (Actual)

September 7, 2018

Study Record Updates

Last Update Posted (Actual)

June 24, 2022

Last Update Submitted That Met QC Criteria

June 23, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4689-17-SMC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

There is no plan for sharing the data

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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