Outcomes of 36 vs 38 Hour Intervals From Ovulation Trigger To Oocyte Pick-Up:A Multi-Center Randomized Controlled Trial

NCT05803655 | Unknown DMC

• 1 other identifier: 2021.267.IRB1.093
• Study Type: interventional
• Target: 850
• Locations: 1 country
• Sites: 7

Brief Summary

Women who undergo assisted reproduction technology (ART) treatment will be eligible for this study. The goal of this randomized clinical trial is to compare the outcomes of ART treatment between women who have 36 and 38 hours interval between the administration of ovulation trigger (ovulation trigger medication initiates oocyte maturation and makes it possible for the egg to be collected by aspiration, during a procedure called oocyte pick-up, OPU) and OPU. The main questions it aims to answer are, does prolonging the trigger-OPU interval to 38-hours improve:

• Maturation rate
• Fertilization rate
• Blastulation rate
• Premature ovulation rate
• Positive pregnancy test rate
• Clinical pregnancy rate
• Live birth rate compared to 36-hours interval?

Conditions

Infertility; IVF

Keywords

oocyte pick-up; in vitro fertilization; oocyte maturation; ovulation trigger; intracytoplasmic sperm injection

Outcome Measures

Primary Outcomes (1)

• Ratio of metaphase-2 oocytes to total number of follicles

  Number of metaphase-2 oocytes / total number of follicles \>10mm prior to oocyte pick-up procedure

  1 day

Secondary Outcomes (12)

• Maturation rate

  2 days

• Fertilization rate

  2 days

• Cleavage rate

  4 days

• Blastulation rate

  7 days

• Premature ovulation rate

  1 day

Other Outcomes (1)

• Total oocyte number

  1 day

Study Arms (2)

36-Hour Group

ACTIVE COMPARATOR

The women randomized to this group will undergo oocyte pick-up procedure 36 hours after the injection of the ovulation triggering agent. The choice for ovulation trigger agent is at the discretion of the treating physician. The intervention is not the drug but the interval.

Other: 36-hour duration between ovulation triggering and oocyte pick-up procedure

38-Hour Group

EXPERIMENTAL

The women randomized to this group will undergo oocyte pick-up procedure 38 hours after the injection of the ovulation triggering agent. The choice for ovulation trigger agent is at the discretion of the treating physician. The intervention is not the drug but the interval.

Other: 38-hour duration between ovulation triggering and oocyte pick-up procedure

Interventions

36-hour duration between ovulation triggering and oocyte pick-up procedure OTHER

36-hour duration between ovulation triggering and oocyte pick-up procedure

36-Hour Group

38-hour duration between ovulation triggering and oocyte pick-up procedure OTHER

38-hour duration between ovulation triggering and oocyte pick-up procedure

38-Hour Group

Eligibility Criteria

• Age: 18 Years - 42 Years
• Gender Eligibility Details: Since ovarian stimulation, ovulation trigger and oocyte pick-up procedure can only be applied to females, we have to limit gender to female participants only.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• To undergo assisted reproductive technology (ART) treatment and planning to undergo embryo transfer procedure within 6 months of oocyte collection
• Female partner to be between 18-42 years old at the time of informed consent
• Both partners to consent to participate in the study and be legally eligible to give consent.

You may not qualify if:

• Female partner to have participated in the study previously.
• Female partner to have a body mass index of 35 kg/m2 or above.
• Female partner to have a systemic disease that may affect ART or pregnancy outcomes (e.g. antiphospholipid syndrome, severe liver dysfunction, diabetes mellitus, history of venous thrombosis, advanced renal or cardiac diseases).
• Presence of congenital uterine anomaly (1-Women whose uterine anomalies are surgically corrected are not excluded; 2- Arcuate uterus is not accepted as a congenital uterine anomaly).
• Presence of submucous or intramural fibroid that distorts the endometrial cavity.
• Diagnosis of stage 3 or 4 endometriosis in the female partner.
• Female partner planned to undergo double ovarian stimulation.
• Known karyotype anomaly in at least one of the partners.
• Diagnosis of azoospermia (no sperm cells in the ejaculate) in the male partner.
• History of recurrent implantation failure \[defined according to the scoring system by Ata et al in 2021 available at https://bit.ly/3huVLOn (Ata B, Kalafat E, Somigliana E. A new definition of recurrent implantation failure on the basis of anticipated blastocyst aneuploidy rates across female age. Fertil Steril. 2021;116(5):1320-1327. doi:10.1016/j.fertnstert.2021.06.045\].
• History of recurrent pregnancy loss \[defined as a history of 2 or more biochemical/clinical pregnancy losses, in accordance with the European Society of Human Reproduction and Embryology(ESHRE) Guideline on the management of recurrent pregnancy loss issued on 1 February 2023, available at https://www.eshre.eu/Guidelines-and-Legal/Guidelines/Recurrent-pregnancy-loss.aspx\].

Sponsors & Collaborators

• Koç University: lead
• Turkish Society of Reproductive Medicine: collaborator

Study Sites (7)

Baskent University

Adana, 01250, Turkey (Türkiye)

RECRUITING

Ankara University

Ankara, 06100, Turkey (Türkiye)

RECRUITING

Hacettepe University

Ankara, 06230, Turkey (Türkiye)

RECRUITING

Uludag University

Bursa, 16059, Turkey (Türkiye)

RECRUITING

Koc University

Istanbul, 34010, Turkey (Türkiye)

RECRUITING

Bahceci Fulya IVF Centre

Istanbul, 34394, Turkey (Türkiye)

RECRUITING

VKF American Hospital

Istanbul, Turkey (Türkiye)

RECRUITING

Related Publications (1)

• Ata B, Kalafat E, Somigliana E. A new definition of recurrent implantation failure on the basis of anticipated blastocyst aneuploidy rates across female age. Fertil Steril. 2021 Nov;116(5):1320-1327. doi: 10.1016/j.fertnstert.2021.06.045. Epub 2021 Jul 28.

  PMID: 34332750 BACKGROUND

Related Links

• ESHRE Guideline on the management of recurrent pregnancy loss

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Engin Turkgeldi, Assoc. Prof

  Koç University

  PRINCIPAL INVESTIGATOR

• Baris Ata, Prof.Dr

  Koç University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Engin Turkgeldi, Assoc.Prof.

CONTACT

00908502508250; engtur@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Only the head-nurse and the patient will not be masked, since one will randomize the patient to a group and give her instructions on how to use the medication, and the other will apply the injection herself. However, allocation will be concealed from the the laboratory team, treating physicians, outcome assessors and investigators. They will not be given information about when the patient applied the injection, and the patient will be instructed not to reveal information regarding her use.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The patient will be randomized to either ''36 hour'' or ''38 hour'' group on the day of ovulation trigger. According to her allocation, she will apply the injection. Except for the difference in the interval between ovulation trigger and oocyte pick-up procedure, women in both arms will undergo exactly the same treatment steps.

Study Record Dates

• First Submitted: March 27, 2023
• First Posted: April 7, 2023
• Study Start: April 27, 2023
• Primary Completion: September 1, 2024
• Study Completion: December 1, 2025
• Last Updated: October 5, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (7)