Low Dose hCG in the Late Follicular Phase

Study Overview
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Brief Summary
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In this study,the investigators compared two protocols for controlled ovarian hyperstimulation in infertility patients requiring IVF. In the control group, the patient undergoes a standard antagonist protocol. In the study group, the administration of gonadotropins is stopped in the late follicular phase and replaced by low dose human chorionic gonadotropins. The primary endpoint of the study is the number of oocytes retrieved in both groups.

Official Title
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Among ICSI Patients Undergoing Antagonist Protocols With Recombinant FSH, Does Replacement of Recombinant FSH by 200 IU of hCG in the Late Follicular Phase Compared With Continuing Recombinant FSH, Result in a Similar Number of Oocytes?

Conditions
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Infertility

Intervention / Treatment
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* Drug: human chorionic gonadotropin
* Drug: recombinant gonadotropins


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: < 36 years on day of randomisation FSH < 12 in the early follicular phase Normal ultrasound scan BMI between 18 and 29 (both inclusive) Randomisation at outpatient clinic Exclusion Criteria: Endometriosis ≥ grade 3 PCO syndrome Poor responder Endocrine or metabolic abnormalities

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 36 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br>Patients undergo a standard antagonist protocol for in-vitro fertilisation, and are stimulated with recombinant gonadotropins. | Drug: recombinant gonadotropins<br>* 200 IU per day during controlled ovarian stimulation<br>* Other names: Puregon, NV Organon, Oss, The Netherlands;|
| Experimental: B<br>Patients are undergo an antagonist protocol for in-vitro fertilisation and are stimulated with recombinant gonadotropins. When the patient has an estradiol value of 600 ng/L or more and when the patient has at least 6 follicles of 12 mm, the administration of gonadotropins is stopped and replaced by low dose human chorionic gonadotropins. | Drug: human chorionic gonadotropin<br>* hCG 200IU in the late follicular phase<br>* Other names: Pregnyl, NV Organon, Oss, The Netherlands;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of oocytes in both treatment groups |  | up to 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of stimulation in both treatment groups, amount of gonadotropins consumed in each treatment group |  | up to 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IVF, infertility, hCG, primary infertility, secondary infertility, patients requiring in-vitro fertilisation