Dual Trigger Versus GnRHa Trigger Combined With Luteal HCG Administration

Last updated: October 27, 2023
Sponsor: Mansoura University
Overall Status: Active - Recruiting

Phase

4

Condition

Infertility

Treatment

GnRHa and HCG

GnRHa then HCG (multiple low-doses)

GnRHa then HCG (single low-dose)

Clinical Study ID

NCT02330770
MSA5
  • Ages 20-35
  • Female

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Women subjected to ICSI through controlled ovarian hyperstimulation (COH) withpituitary downregulation by GnRH antagonist.
  • Presence of risk for development of OHSS: 1) previous moderate or severe OHSS; 2) PCOSor polycystic ovary on ultrasound scan; 3) antral follicle count (AFC) > 14 in bothovaries; 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 theday of triggering of oocyte maturation.

Exclusion

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.

Study Design

Total Participants: 225
Treatment Group(s): 3
Primary Treatment: GnRHa and HCG
Phase: 4
Study Start date:
June 06, 2016
Estimated Completion Date:
December 31, 2024

Study Description

The GnRH antagonist fixed protocol will be used for controlled ovarian hyperstimulation (COH). Transvaginal sonography (TVS) scan will be performed regularly for monitoring of the follicular growth (folliculometry). When there will be at least 3 leading follicles > 18 mm in diameter, women will be randomized into 3 groups; group A (dual trigger group), group B (single low-dose HCG group) and group C (multiple low-doses HCG group). In group A, final oocyte maturation will be triggered by dual administration of 0.2 mg of GnRHa preparation (Triptorelin) SC and 1500 IU of HCG preparation IM. In group B, final oocyte maturation will be triggered by administration of 0.2 mg Triptorelin SC then a single IM bolus of 1500 IU HCG will by administered 35-37 hours after GnRHa trigger (1 hour after oocyte retrieval). In group C, final oocyte maturation will be triggered by administration of 0.2 mg Triptorelin SC then 3 IM boluses of 500 IU HCG will be administered day 1, day 4 and day 7 after oocyte retrieval. In all women, oocyte retrieval will be performed 34-36 hours after trigger and endometrial preparation for embryo transfer (ET) will be started on the day of oocyte retrieval by giving 400 mg vaginal natural progesterone supplement once daily plus 4 mg oral estradiol valerate once daily.

Connect with a study center

  • Private fertility care centers

    Mansoura, Dakahlia
    Egypt

    Site Not Available

  • Fertility Care Unit (FCU) in Mansoura University Hospital

    Mansourah, Dakahlia 35111
    Egypt

    Active - Recruiting

  • Private fertility care centers

    Mansourah, Dakahlia
    Egypt

    Active - Recruiting

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