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Trial · Interventional

Status unknownPhase 4Registry data

Dual Trigger Versus GnRHa Trigger Combined With Luteal HCG Administration

NCTNCT02330770 (opens ClinicalTrials.gov in a new tab)Other idMSA5
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Status unknown
Phase
Phase 4
Enrollment
225 participants (estimated)
Sponsor
Mansoura University · Other
Design
Randomized · Open label (no masking)
Countries
1 country

Egypt

Start
6 Jun 2016
Primary completion
31 Dec 2024 (estimated)
Completion
31 Dec 2024 (estimated)
First posted
5 Jan 2015 (estimated)
Last update posted
30 Oct 2023
Conditions
Infertility

Timeline

1 trial

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20162018202020222024
  1. Ph 4

    Dual Trigger Versus GnRHa Trigger Combined With Luteal HCG Administration

    NCT02330770

    6 Jun 2016 to est. 31 Dec 2024

Registry summary

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

Comparing the reproductive outcomes of intracytoplasmic sperm injection (ICSI) cycles in women at risk of ovarian hyperstimulation syndrome (OHSS) subjected to gonadotropin releasing hormone (GnRH) antagonist protocol followed by trigger with concomitant GnRH agonist (GnRHa) and low-dose human chorionic gonadotropin (HCG) administration (dual trigger), GnRHa trigger with single luteal low-dose HCG or GnRHa trigger with multiple luteal low-doses HCG

Interventions

  • GnRHa and HCGDrug
  • GnRHa then HCG (single low-dose)Drug
  • GnRHa then HCG (multiple low-doses)Drug

Arms3

  • Active comparator

    Dual trigger group

    Trigger with concomitant GnRHa and HCG (single low-dose) administration

  • Active comparator

    Single low-dose HCG group

    Trigger with GnRHa then HCG (single low-dose) administration in luteal phase

  • Active comparator

    Multiple low-doses HCG group

    Trigger with GnRHa then HCG (multiple low-doses) administration in luteal phase

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Clinical pregnancy rate

    Time frame · 6 weeks after embryo transfer

    Registry description

    Number of clinical pregnancies (defined as presence of at least one intrauterine gestational sac with fetal pole and cardiac activity on TVS scan at 4-6 weeks after the ET) divided by the number of ET procedures

Secondary outcomes(4)

  1. Oocyte maturation rate

    Time frame · On day of oocyte retrieval

    Registry description

    Number of mature oocytes divided by the number of retrieved oocytes

  2. Incidence of early OHSS

    Time frame · Within 9 days of final triggering of oocyte maturation

    Registry description

    Incidence of OHSS within 9 days of final triggering of oocyte maturation

  3. Implantation rate

    Time frame · 6 weeks after embryo transfer

    Registry description

    Number of gestational sacs on TVS scan at 4-6 weeks after ET divided by the number of transferred embryos

  4. Miscarriage rate

    Time frame · 12 weeks gestational age

    Registry description

    Number of first trimester miscarriages (before 12 weeks gestational age) divided by the number of clinical pregnancies

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 20 Years up to 35 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Women subjected to ICSI through controlled ovarian hyperstimulation (COH) with pituitary downregulation by GnRH antagonist. * Presence of risk for development of OHSS: 1) previous moderate or severe OHSS; 2) PCOS or polycystic ovary on ultrasound scan; 3) antral follicle count (AFC) \> 14 in both ovaries; 4) basal serum AMH level \> 3.36 ng/ml; 5) \> 14 follicles with diameter of ≥ 11 mm on the day of triggering of oocyte maturation; 6) E2 level \> 3000 pg/ml on the day of triggering of oocyte maturation. Exclusion Criteria: * Age \< 20 years or \> 35 years. * BMI \< 19 kg/m2 or \> 35 kg/m2. * Moderate or severe endometriosis. * Hydrosalpinx. * Uterine abnormalities or myoma. * Previous uterine surgery. * Use of alternative techniques to minimize the risk of OHSS.

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