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Agonist Trigger With HCG Luteal Supplementation vs HCG Trigger With Progesterone Luteal Supplementation in Antagonist Controlled HyperstimulationCycle

Sponsor
Ain Shams University (Other)
Overall Status
Completed
CT.gov ID
NCT04846218
Collaborator
(none)
100
Enrollment
1
Location
2
Arms
42
Duration (Months)
2.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of the current study is to compare agonist trigger and HCG luteal support vs standard HCG trigger and progesterone luteal supplementation in antagonist controlled hyperstimulation cycle as regards to clinical pregnancy rate.

Condition or Disease Intervention/Treatment Phase
N/A

Detailed Description

Prospective Interventional randomized pilotstudy on patients undergoing controlled ovarian hyperstimulation.

All patients will receive a fixed dose of 150-300 IU recombinant FSH (Gonal-F; Sereno Laboratories,Madrid, Spain) for ovarian stimulation according to age, BMI and antral follicle count (AFC).

After 6 days of stimulation, FSH will be adjusted according to ovarian response.

Premature LH surge will be prevented with 0.25 mg of a GnRH antagonist (Cetrotide; Serono International, Geneva, Switzerland) starting on day 6 when two or more follicles reach a size of 18-20 mm, trigger of ovulation will be done and followed by luteal phase support according to the protocol assigned for each group.

Group 1:

A single dose of 0.2 mg triptorelin (Decapeptyl® Ipsen Pharmaceutical Company, France) and follow up with daily 125 IU HCG injections

Group 2:

A single dose of HCG 10000 IU was given followed by progesterone supplementation with 100mg IM (Prontogest®).

Study Design

Study Type:
Interventional
Actual Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
Comparison Between Agonist Trigger With HCG Luteal Phase Supplementation vs HCG Trigger With Progesterone Luteal Phase Supplementation in Antagonist Controlled HyperstimulationCycle Regarding Clinical Pregnancy Rate
Study Start Date :
Dec 1, 2016
Actual Primary Completion Date :
Jan 1, 2020
Actual Study Completion Date :
Jun 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Group 1

They will receive a single dose of 0.2 mg triptorelin (Decapeptyl® Ipsen Pharmaceutical Company, France) and follow up with daily 125 IU HCG injections

Drug: hCG

Drug: Triptorelin
Other Names:
  • Decapeptyl

    		•
    Active Comparator: Group 2

    They will receive a single dose of HCG 10000 IU was given followed by progesterone supplementation with 100mg IM (Prontogest®).

    Drug: hCG

    Drug: Progesterone
    Other Names:
  • Prontogest

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Clinical pregnancy rate [1 year]

      Clinical pregnancy diagnosed by pregnancy test and ultrasound

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 39 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Age between 20 and 39 years.

    • Body mass index between 18 and 30.

    • Unexplained infertility or male factor infertility

    Exclusion Criteria:

    • Endocrinological disorder eg.:hyperprolactenemia, Hypo or hyper thyrodism

    • More than 2 previous attemptsof IVF

    • Any uterine anatomical anomaly.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 AinShams Maternity Hospital Cairo Egypt 002

    Sponsors and Collaborators

    • Ain Shams University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    maii medhat nawara, Principal investigator, Ain Shams University
    ClinicalTrials.gov Identifier:
    NCT04846218
    Other Study ID Numbers:
    • AP-45WE
    First Posted:
    Apr 15, 2021
    Last Update Posted:
    Nov 18, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Infertility
    Infertility, Female
    Triptorelin Pamoate
    Progesterone

    Study Results

    No Results Posted as of Nov 18, 2021