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

Primary Purpose

Infertility, Female

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
hCG
Progesterone
Triptorelin
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility, Female

Eligibility Criteria

20 Years - 39 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • AinShams Maternity Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group 1

Group 2

Arm Description

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

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

Outcomes

Primary Outcome Measures

Clinical pregnancy rate
Clinical pregnancy diagnosed by pregnancy test and ultrasound

Secondary Outcome Measures

Full Information

First Posted
December 31, 2016
Last Updated
November 17, 2021
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT04846218
Brief Title
Agonist Trigger With HCG Luteal Supplementation vs HCG Trigger With Progesterone Luteal Supplementation in Antagonist Controlled HyperstimulationCycle
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 Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
December 2016 (undefined)
Primary Completion Date
January 2020 (Actual)
Study Completion Date
June 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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®).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Female

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Active Comparator
Arm Description
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
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
They will receive a single dose of HCG 10000 IU was given followed by progesterone supplementation with 100mg IM (Prontogest®).
Intervention Type
Drug
Intervention Name(s)
hCG
Intervention Type
Drug
Intervention Name(s)
Progesterone
Other Intervention Name(s)
Prontogest
Intervention Type
Drug
Intervention Name(s)
Triptorelin
Other Intervention Name(s)
Decapeptyl
Primary Outcome Measure Information:
Title
Clinical pregnancy rate
Description
Clinical pregnancy diagnosed by pregnancy test and ultrasound
Time Frame
1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
AinShams Maternity Hospital
City
Cairo
ZIP/Postal Code
002
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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