Dual Trigger Versus GnRHa Trigger Combined With Luteal HCG Administration

Mansoura University

Status and phase: Enrolling; Phase 4

Conditions: Infertility

Treatments: Drug: GnRHa and HCG; Drug: GnRHa then HCG (single low-dose); Drug: GnRHa then HCG (multiple low-doses)

Study type: Interventional

Funder types: Other

Identifiers

NCT02330770

MSA5

Details and patient eligibility

About

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

Full 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.

Enrollment: 225 estimated patients

Sex: Female

Ages: 20 to 35 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

225 participants in 3 patient groups

Dual trigger group

Active Comparator group

Description:

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

Treatment:

Drug: GnRHa and HCG

Single low-dose HCG group

Active Comparator group

Description:

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

Treatment:

Drug: GnRHa then HCG (single low-dose)

Multiple low-doses HCG group

Active Comparator group

Description:

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

Treatment:

Drug: GnRHa then HCG (multiple low-doses)