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Dual Trigger Versus GnRHa Trigger Combined With Luteal HCG Administration

Information source: Mansoura University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Infertility

Intervention: GnRHa and HCG (Drug); GnRHa then HCG (Drug); GnRHa then HCG (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Mansoura University

Official(s) and/or principal investigator(s):
Mohamed S Abdelhafez, Dr, Principal Investigator, Affiliation: Mansoura University
Ahmed M Badawy, Prof, Study Chair, Affiliation: Mansoura University

Overall contact:
Mohamed S Abdelhafez, Dr, Phone: +201124442800, Email: msabdelhafez@gmail.com


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

Clinical Details

Official title: Dual Trigger Versus Gonadotropin Releasing Hormone Agonist Trigger Combined With Luteal Human Chorionic Gonadotropin Administration

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Primary outcome: Clinical pregnancy rate

Secondary outcome:

Oocyte maturation rate

Incidence of early OHSS

Implantation rate

Miscarriage rate

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.


Minimum age: 20 Years. Maximum age: 35 Years. Gender(s): Female.


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.

Locations and Contacts

Mohamed S Abdelhafez, Dr, Phone: +201124442800, Email: msabdelhafez@gmail.com

Fertility Care Unit (FCU) in Mansoura University Hospital, Mansoura, Dakahlia 35111, Egypt; Recruiting
Mohamed S Abdelhafez, Dr, Phone: +20112442800, Email: msabdelhafez@gmail.com

Private fertility care centers, Mansoura, Dakahlia, Egypt; Recruiting

Additional Information

Starting date: January 2015
Last updated: May 2, 2015

Page last updated: August 23, 2015

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