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

• Conditions: Infertility; Ovarian Hyperstimulation Syndrome

• Registration Number: NCT02329483
• Lead Sponsor: Bagcilar Training and Research Hospital

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2014-12
• Study First Submitted: 2014-12-29
• Study First Submitted QC: 2014-12-30
• Study First Posted: 2014-12-31
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-04
• Last Update Posted: 2015-04-07
• Primary Completion: 2015-05
• Study Completion: 2015-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Blood androstenedione and testosterone levels.	within 10-20 days	Patterns of blood androstenedione and testosterone levels with respect to the regular monitoring parameters and relations to secondary outcomes.

Secondary Outcome Measures

Name	Time	Method
Pregnancy	20-30 days	blood hCG level \>10mIU/mlt
Cycle cancellation	within 10-20 days	cancellation of treatment despite 2 rounds of dose step-up
Ovarian hyperstimulation	10-30 days	Enlarged ovaries, abdominal ascites, pleural effusion, hemoconcentration, abdominal swelling
Need for dose step-up	7-14 days	if at the 7th day of a dose, no follicle(s)\>10mm are observed then the dose is increased

Trial Locations

Locations (1)

Bagcilar Training and Research Hospital; 🇹🇷 Istanbul, Turkey