Monitoring the Early Follicular Phase With Androstenedione in Low-dose Step-up Ovulation Induction in High Responders

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

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-12-31

Study Completion Date

2015-06-30

Brief Summary

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This study aims to predefine the threshold FSH doses during the early follicular phases in low- dose step-up ovulation induction cycles used to treat anticipated high responders by monitoring total testosterone and androstenedione blood levels. The blood levels of total testosterone and androstenedione levels will be measured in patients at the starting day and at every control day when vaginal sonographic folliculometries and blood estradiol measurements are made. Hence, we are aiming to define an early monitoring parameter by which we will be able to define a follicular response to treatment before estradiol rise or apparently selected follicular growth.

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Detailed Description

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50 patients with anticipated high ovarian response, who are being planned to be conventionally treated with low-dose step-up ovulation induction and intrauterine insemination will be analysed in this study. At every control day including the start day, blood samples taken for blood estradiol (and if required progesterone) measurements will be used to measure blood androstenedione and total testosterone levels, as well. Hence, we will have defined an early parameter for defining follicular response in the first 5-7 days of low-dose step-up ovulation induction. Low-dose step-up ovulation induction will be started at 50-75Units/day of rhFSH and the dose will be increased at not earlier than the 7th day at an increment of +37,5Units/day unless a response is observed ( which is at least a 10mm follicle, selected for growth). If more than 3 dominant follicles are selected, the cycle will be cancelled. Otherwise, when at least one follicle \>16mm is obtained, a 150Microgram sc. injection will be administered for ovulation trigger and intrauterine insemination made at the 34th-36th hours.

Conditions

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Infertility Ovarian Hyperstimulation Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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High responder infertile patients

Ovarian high responder patients who are being planned for low-dose step-up protocol ovulation induction and intrauterine insemination.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Primary/Secondary infertile women; aged 20-35 years of age
* High ovarian response to ovulation induction anticipated.(Antral follicle count on the 3rd day of cycle\>10)
* Mild male factor or normal sperm parameters
* Normal anatomic findings with the HSG
* Eugonadotropic
* Normal blood prolactin and TSH levels

Exclusion Criteria

* Amenorrheic women
* Women with Diabetes Mellitus
* Body Mass Index: \<22 or \>30
* Age\<20 or \>35 years old
* Hormonal abnormalities: regarding prolactin, TSH
* Hypo- or Hypergonadotropic women
* Additional medical or surgical disease
* Ovarian cysts
* Previous ovarian surgery

Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Responsible Party

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Eser Sefik Ozyurek

Operator Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR