Clinical trial NCT02330770: Dual Trigger Versus GnRHa Trigger Combined With Luteal HCG Administration
Official title: Dual Trigger Versus Gonadotropin Releasing Hormone Agonist Trigger Combined With Luteal Human Chorionic Gonadotropin Administration
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Infertility
Keywords: GnRHa trigger
Luteal phase support
OHSS
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2015-01-05
Enrollment: 225
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Clinical pregnancy rate
timeFrame: 6 weeks after embryo transfer
Secondary outcomes:
measure: Oocyte maturation rate
timeFrame: On day of oocyte retrieval
measure: Incidence of early OHSS
timeFrame: Within 9 days of final triggering of oocyte maturation
measure: Implantation rate
timeFrame: 6 weeks after embryo transfer
measure: Miscarriage rate
timeFrame: 12 weeks gestational age
Other outcomes:
Locations:
city: Mansourah
country: Egypt
facility: Fertility Care Unit (FCU) in Mansoura University Hospital
state: Dakahlia
city: Mansourah
country: Egypt
facility: Private fertility care centers
state: Dakahlia
Study officials:
affiliation: Mansoura University
name: Mohamed S Abdelhafez, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Port Said University
name: Waleed El-refaie, Dr
role: STUDY_DIRECTOR
References: