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Trial record 74 of 415 for:    Gonadotrophin, Chorionic AND Choriogonadotropin Alfa

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

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ClinicalTrials.gov Identifier: NCT03825445
Recruitment Status : Completed
First Posted : January 31, 2019
Last Update Posted : January 31, 2019
Sponsor:
Information provided by (Responsible Party):
Hue University of Medicine and Pharmacy

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.

Condition or disease Intervention/treatment Phase
Ovulation Induction Drug: GnRHa (Fertipeptil 0.1mg) Drug: hCG (Pregnyl 5000IU) Not Applicable

Detailed Description:

Study design A prospective randomized comparative study was conducted at Hue University Hospital in Vietnam from April 2016 to June 2017 in 197 infertile women undergoing IUI. The study was approved by the Ethics Committee at Hue University of Medicine and Pharmacy.

Study population A total of 217 women were recruited into the sample at the first stage. Inclusion criteria were women with 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 and there were 197 infertile women who obtained at least 1 mature follicle at the first cycle were included in analysis. Patients were randomly assigned to receive either GnRHa trigger (n=98 cycles) or hCG trigger (n= 99 cycles) for ovulation trigger.

Intervention All patients included in the study were subjected to complete history and physical. Patients with a history of abnormal menstrual cycles (amenorrhea, oligomenorrhea) underwent ovarian stimulation. Stimulation was 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 either two doses of GnRH-a (Fertipeptil 0.1mg x 2 vial; Ferring Pharm Co, Switzerland) or hCG (Pregnyl 5000IU; Organon Pharm Co, Nertheland) for ovulation trigger.

IUI was then performed with sperm preparation by radiant centrifugation 36 hours after the trigger. Luteal phase support with progesterone 200mg daily (Utrogestan; Besins Health Care Com, Belgium) was started in the day of IUI.

Assessment of outcomes Patients returned for ultrasound monitoring 24 hours after IUI to confirm ovulation which is determined by the accumulation of free fluid in peritoneum at Douglas sac and disappearance of the previous mature follicles.

Serum β-human chorionic gonadotropin (βhCG) was collected 14 days after insemination. A biochemical pregnancy was defined by βhCG concentration > 25 mIU/ml (Shapphire 350; Cork Com, Ireland). Two weeks after a positive βhCG test, the patient returned for an ultrasound appointment. A clinical pregnancy was defined as the presence of gestational sac with fetal cardiac activity.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 197 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: Double (Participant, Investigator)
Masking Description: Odd even rule
Primary Purpose: Treatment
Official Title: GnRH Agonist Versus hCG Trigger in Ovulation Induction With Intrauterine Insemination: a Randomized Controlled Trial
Actual Study Start Date : April 1, 2016
Actual Primary Completion Date : June 30, 2017
Actual Study Completion Date : June 30, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: GnRHa trigger
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)
Two doses of GnRH-a (Fertipeptil 0.1mg x 2 vial) for ovulation trigger after ovarian stimulation for IUI.

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




Primary Outcome Measures :
  1. The effectiveness of GnRHa versus hCG in ovulation induction [ Time Frame: 14 months ]
    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.

  2. The effectiveness of GnRHa versus hCG in pregnancy rate [ Time Frame: 14 months ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Infertile women with ovulation stimulation
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • No mature follicle
  • Disagree to be enrolled

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03825445


Sponsors and Collaborators
Hue University of Medicine and Pharmacy
Investigators
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Study Director: Minh Tam Le, Prof.MD.PhD Hue University of Medicine and Pharmacy, Hue University

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Responsible Party: Hue University of Medicine and Pharmacy
ClinicalTrials.gov Identifier: NCT03825445     History of Changes
Other Study ID Numbers: H2016/205
First Posted: January 31, 2019    Key Record Dates
Last Update Posted: January 31, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Hue University of Medicine and Pharmacy:
GnRH agonist trigger
hCG trigger
ovulation induction
Additional relevant MeSH terms:
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Chorionic Gonadotropin
Deslorelin
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Reproductive Control Agents
Physiological Effects of Drugs