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

Study Overview
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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®).

Official Title
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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

Conditions
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Infertility, Female

Intervention / Treatment
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* Drug: hCG
* Drug: Progesterone
* Drug: Triptorelin


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 39 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1<br>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<br> <br> Drug: Triptorelin<br> <br> * Other names: Decapeptyl;|
| Active Comparator: Group 2<br>They will receive a single dose of HCG 10000 IU was given followed by progesterone supplementation with 100mg IM (Prontogest®). | Drug: hCG<br> <br> Drug: Progesterone<br> <br> * Other names: Prontogest;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical pregnancy rate | Clinical pregnancy diagnosed by pregnancy test and ultrasound | 1 year |