GnRH Agonist Versus hCG Trigger in Ovulation Induction With Intrauterine Insemination.

NCT03825445 | Completed DMC

• 1 other identifier: H2016/205
• Study Type: interventional
• Target: 197
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to compare clinical pregnancy rates (CPR) in patients who are administered either Gonadotropin-releasing hormone agonists (GnRHa) or human chorionic gonadotropin (hCG) for ovulation trigger in intrauterine insemination (IUI) cycles. A prospective randomized comparative study was conducted at Hue University Hospital in Vietnam. Total of 197 infertile women were randomly assigned to receive either GnRHa trigger (n=98 cycles) or hCG trigger (n= 99 cycles) for ovulation trigger. Patients returned for ultrasound monitoring 24 hours after IUI to confirm ovulation. A clinical pregnancy was defined as the presence of gestational sac with fetal cardiac activity.

Conditions

Ovulation Induction

Keywords

GnRH agonist trigger; hCG trigger; ovulation induction

Outcome Measures

Primary Outcomes (2)

• The effectiveness of GnRHa versus hCG in ovulation induction

  To compare the ovulation rate of patients who were triggered with GnRHa versus hCG in patients undergoing either natural cycle or controlled ovarian stimulation with gonadotropins and IUI.

  14 months

• The effectiveness of GnRHa versus hCG in pregnancy rate

  To compare the pregnancy rate of patients who were triggered with GnRHa versus hCG in patients undergoing either natural cycle or controlled ovarian stimulation with gonadotropins and IUI.

  14 months

Study Arms (2)

GnRHa trigger

EXPERIMENTAL

Infertile patients underwent ovarian stimulation, started on cycle day eight with 75 IU Menogon (Ferring Pharm Co, Switzerland) daily. Ultrasound monitoring was required after every 2-3 days of stimulation and adjustments to dose and duration were tailed according the patient's response. Ovulation was triggered when at least one and no more than 3 follicles reached ≥18mm in diameter. Patients were then randomly assigned to receive two doses of GnRH-a (Fertipeptil 0.1mg x 2 vial; Ferring Pharm Co, Switzerland) for ovulation trigger.

Drug: GnRHa (Fertipeptil 0.1mg)

hCG trigger

EXPERIMENTAL

Infertile patients underwent ovarian stimulation, started on cycle day eight with 75 IU Menogon (Ferring Pharm Co, Switzerland) daily. Ultrasound monitoring was required after every 2-3 days of stimulation and adjustments to dose and duration were tailed according the patient's response. Ovulation was triggered when at least one and no more than 3 follicles reached ≥18mm in diameter. Patients were then randomly assigned to receive hCG (Pregnyl 5000IU; Organon Pharm Co, Nertheland) for ovulation trigger.

Drug: hCG (Pregnyl 5000IU)

Interventions

GnRHa (Fertipeptil 0.1mg) DRUG

Two doses of GnRH-a (Fertipeptil 0.1mg x 2 vial) for ovulation trigger after ovarian stimulation for IUI.

GnRHa trigger

hCG (Pregnyl 5000IU) DRUG

hCG (Pregnyl 5000IU) for ovulation trigger after ovarian stimulation for IUI.

hCG trigger

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Infertile women with ovulation stimulation
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Infertile women who were indicated for IUI cycles
• bilateral tubal patency
• at least one follicle ≥ 18mm in diameter on the day of trigger, and
• men with more than five millions total motile sperm after preparation.
• Only the first cycles of IUI were studied

You may not qualify if:

• No mature follicle
• Disagree to be enrolled

Sponsors & Collaborators

• Hue University of Medicine and Pharmacy: lead

MeSH Terms

Interventions

Chorionic Gonadotropin

Intervention Hierarchy (Ancestors)

Gonadotropins; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Placental Hormones; Peptides; Amino Acids, Peptides, and Proteins; Pregnancy Proteins; Proteins

Study Officials

• Minh Tam Le, Prof.MD.PhD

  Hue University of Medicine and Pharmacy, Hue University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Odd even rule
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A prospective randomized comparative study was conducted at Hue University Hospital in Vietnam. Total of 197 infertile women were randomly assigned to receive either GnRHa trigger (n=98 cycles) or hCG trigger (n= 99 cycles) for ovulation trigger. Patients returned for ultrasound monitoring 24 hours after IUI to confirm ovulation.

Study Record Dates

• First Submitted: January 11, 2019
• First Posted: January 31, 2019
• Study Start: April 1, 2016
• Primary Completion: June 30, 2017
• Study Completion: June 30, 2017
• Last Updated: January 31, 2019

Record last verified: 2019-01