Dual Trigger" in IVF Patients at High Risk of Ovarian Hyper Stimulation Syndrome

NCTNCT05638529Other id17-0302-A

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Overview

Status: Status unknown
Phase: Phase 4
Enrollment: 80 participants (actual)
Sponsor: Mount Sinai Hospital, Canada · Other
Design: Randomized · Quadruple masking
Countries: 1 country
Canada
Start: 1 May 2019
Primary completion: 31 Dec 2023 (estimated)
Completion: 31 Dec 2023 (estimated)
First posted: 6 Dec 2022
Last update posted: 3 Jul 2023
Conditions: Ovarian Hyperstimulation Syndrome · Infertility, Female

Timeline

1 trial

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

201920202021202220232024

Ph 4
Dual Trigger" in IVF Patients at High Risk of Ovarian Hyper Stimulation Syndrome
NCT05638529
1 May 2019 to est. 31 Dec 2023

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The present study aims to evaluate whether the use of a "dual trigger" can improve IVF outcomes, compared to GnRH agonist (GnRH-a) alone, in patients at high risk of OHSS undergoing a freeze-all cycle. By examining freeze-all cycles with frozen embryo transfer(s) (FET) only, we eliminate the potential confounding issue of inadequate luteal support to the endometrium and focus primarily on the effect of a "dual trigger" on oocyte quality and embryo potential. To our best knowledge, there have been no randomized, controlled trials conducted to address this hypothesis.

Interventions

Pregnyl (1,500) IUDrug
1.5 mL of normal salineDrug

Arms2

Experimental
Treatment Arm- Group A
A subcutaneous injection of a GnRH agonist (Suprefact 0.5 mg) and a separate intramuscular injection of hCG (Pregnyl 1,500 IU).
Placebo comparator
Control Arm- Group B
A subcutaneous injection of a GnRH agonist (Suprefact 0.5 mg) and a separate intramuscular injection of normal saline (1.5 mL) (sham-placebo).

Primary outcomes1

Outcomes the sponsor listed as primary.

Total number of Day 5 embryos
Time frame · after 5 days of oocyte fertilization
Registry description
Total number of "good quality" Day 5 embryos available for cryopreservation.

Secondary outcomes(11)

Total number of oocytes retrieved per cycle.
Time frame · within 1-2 days of oocyte retrieval
Total number of mature oocytes (MII) retrieve per IVF/ICSI cycle.
Time frame · 2-3 days after oocyte retrieval
Total number of fertilized zygotes.
Time frame · 3-5 days after the egg retrieval
Fertilization rate
Time frame · 3-5 days after the egg retrieval
Registry description
Number of 2PN zygote(s) divided by the number of mature oocyte(s) fertilized per IVF/ICSI cycle OR Number of 2PN zygote(s) divided by the number of oocytes incubated with at least 10,000 sperm per IVF cycle.
Total number of Day 3 embryos.
Time frame · 3 days after the fertilization of oocyte
Pregnancy Rate
Time frame · Upto 13 weeks after the embryo transfer
Registry description
A serum b-hCG \> 5 mIU/mL per transfer
Clinical pregnancy rate
Time frame · Upto 13 weeks after the embryo transfer
Registry description
Number of gestational sac(s) with a positive fetal heart per transfer.
Implantation rate
Time frame · 3-4 weeks after implantation of embryos
Registry description
Number of gestational sac(s) divided by the number of embryo(s) transferred per FET.
Miscarriage rate
Time frame · Within 20 weeks from the date of the clinical intrauterine pregnancy confirmation ultrasount
Registry description
The number of spontaneous pregnancy losses before 20 weeks gestation divided by the number of clinical pregnancies
Live birth rate
Time frame · Per embryo(s) transferred during the study period and follow-up for up to 10 months after last transfer.]
Registry description
The number of live born neonates over 24 weeks gestation divided by the number of clinical pregnancies
Incidence of moderate to critical OHSS
Time frame · Upto 2 weeks from the date of intervention
Registry description
Based on the classification criteria by Mathur et al. (2007).

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: Female
Age: from 18 Years up to 40 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * They are between the ages of 18 and 40. * They are undergoing IVF treatment with a GnRH antagonist protocol. * During their current treatment cycle, they have at least one of the following risk factors for OHSS: * Greater or equal to 13 follicles measuring at least 11 mm on the day of trigger. * Serum estradiol levels greater or equal to 15,000 pmol/L on the day of trigger. Exclusion Criteria: * They are using a GnRH agonist protocol (which is a contraindication to using a GnRH agonist trigger). * They are planning on using a "dual trigger" (based on poor outcomes in a previous IVF cycle using a GnRH agonist trigger). * They have a low ovarian reserve (AFC \< 7 follicles or AMH \< 10 pmol/L). * They have had a previous failed GnRH agonist trigger. * They have a known diagnosis of hypogonadotropic hypogonadism. * They have had a previous adverse or allergic reaction to GnRH agonist in the past. * They are using surgically retrieved sperm. * They are undergoing treatment for fertility preservation (oncofertility patients). * They have a history of recurrent implantation failure (defined as no clinical pregnancy after transfer of \> 4 good-quality embryos). * They have any congenital or acquire uterine anomalies distorting the uterine cavity. * If serum estradiol levels are equal or exceed 28,000 pmol/L on the day of trigger

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