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

NCT ID: NCT04846218

Last Updated: 2021-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2020-06-30

Brief Summary

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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

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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®).

Conditions

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Infertility, Female

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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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

Group Type ACTIVE_COMPARATOR

hCG

Intervention Type DRUG

Triptorelin

Intervention Type DRUG

Group 2

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

Group Type ACTIVE_COMPARATOR

hCG

Intervention Type DRUG

Progesterone

Intervention Type DRUG

Interventions

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hCG

Intervention Type DRUG

Progesterone

Intervention Type DRUG

Triptorelin

Intervention Type DRUG

Other Intervention Names

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Prontogest Decapeptyl

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

39 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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maii medhat nawara

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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AinShams Maternity Hospital

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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AP-45WE

Identifier Type: -

Identifier Source: org_study_id