Dual Trigger Versus GnRHa Trigger Combined With Luteal HCG Administration

NCT02330770 | Unknown Phase 4

• 1 other identifier: MSA5
• Study Type: interventional
• Target: 225
• Locations: 1 country
• Sites: 2

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

Conditions

Infertility

Keywords

GnRHa trigger; Luteal phase support; OHSS

Outcome Measures

Primary Outcomes (1)

• Clinical pregnancy rate

  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

  6 weeks after embryo transfer

Secondary Outcomes (4)

• Oocyte maturation rate

  On day of oocyte retrieval

• Incidence of early OHSS

  Within 9 days of final triggering of oocyte maturation

• Implantation rate

  6 weeks after embryo transfer

• Miscarriage rate

  12 weeks gestational age

Study Arms (3)

Dual trigger group

ACTIVE COMPARATOR

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

Drug: GnRHa and HCG

Single low-dose HCG group

ACTIVE COMPARATOR

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

Drug: GnRHa then HCG (single low-dose)

Multiple low-doses HCG group

ACTIVE COMPARATOR

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

Drug: GnRHa then HCG (multiple low-doses)

Interventions

GnRHa and HCG DRUG

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

Also known as: Decapeptyl and Pregnyl

Dual trigger group

GnRHa then HCG (single low-dose) DRUG

Final oocyte maturation will be triggered by administration of 0.2 mg Triptorelin SC then a single IM bolus of 1500 IU HCG will be administered 35-37 hours after GnRHa trigger (1 hour after oocyte retrieval)

Also known as: Decapeptyl then Pregnyl

Single low-dose HCG group

GnRHa then HCG (multiple low-doses) DRUG

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

Also known as: Decapeptyl then Pregnyl

Multiple low-doses HCG group

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (2)

Fertility Care Unit (FCU) in Mansoura University Hospital

Al Mansurah, Dakahlia Governorate, 35111, Egypt

RECRUITING

Private fertility care centers

Al Mansurah, Dakahlia Governorate, Egypt

RECRUITING

MeSH Terms

Conditions

Infertility

Interventions

Triptorelin Pamoate; Chorionic Gonadotropin; Single Person

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Gonadotropins; Placental Hormones; Pregnancy Proteins; Marital Status; Family Characteristics; Demography; Population Characteristics; Socioeconomic Factors

Study Officials

• Mohamed S Abdelhafez, Dr

  Mansoura University

  PRINCIPAL INVESTIGATOR

• Waleed El-refaie, Dr

  Port Said University

  STUDY DIRECTOR

Central Study Contacts

Mohamed S Abdelhafez, Dr

CONTACT

+201144523366; msabdelhafez@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: January 1, 2015
• First Posted: January 5, 2015
• Study Start: June 6, 2016
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: October 30, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)