Dual Trigger Versus GnRHa Trigger Combined With Luteal HCG Administration

Phase 4

Recruiting

• Conditions: Infertility
• Interventions: Drug: GnRHa and HCG; Drug: GnRHa then HCG (single low-dose); Drug: GnRHa then HCG (multiple low-doses)

• Registration Number: NCT02330770
• Lead Sponsor: Mansoura University

Brief 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

Detailed 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.

Study Timeline

• Study First Submitted: 2015-01-01
• Study First Submitted QC: 2015-01-01
• Study First Posted: 2015-01-05
• Study Start: 2016-06-06
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-27
• Last Update Posted: 2023-10-30
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 225

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dual trigger group	GnRHa and HCG	Trigger with concomitant GnRHa and HCG (single low-dose) administration
Single low-dose HCG group	GnRHa then HCG (single low-dose)	Trigger with GnRHa then HCG (single low-dose) administration in luteal phase
Multiple low-doses HCG group	GnRHa then HCG (multiple low-doses)	Trigger with GnRHa then HCG (multiple low-doses) administration in luteal phase

Primary Outcome Measures

Name	Time	Method
Clinical pregnancy rate	6 weeks after embryo transfer	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 Outcome Measures

Name	Time	Method
Incidence of early OHSS	Within 9 days of final triggering of oocyte maturation	Incidence of OHSS within 9 days of final triggering of oocyte maturation
Oocyte maturation rate	On day of oocyte retrieval	Number of mature oocytes divided by the number of retrieved oocytes
Implantation rate	6 weeks after embryo transfer	Number of gestational sacs on TVS scan at 4-6 weeks after ET divided by the number of transferred embryos
Miscarriage rate	12 weeks gestational age	Number of first trimester miscarriages (before 12 weeks gestational age) divided by the number of clinical pregnancies

Trial Locations

Locations (2)

Fertility Care Unit (FCU) in Mansoura University Hospital; 🇪🇬 Mansourah, Dakahlia, Egypt

Private fertility care centers; 🇪🇬 Mansourah, Dakahlia, Egypt