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

Sponsor

Bagcilar Training and Research Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT02329483

Collaborator

(none)

Enrollment

Location

Duration (Months)

8.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Infertility Ovarian Hyperstimulation Syndrome

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 Design

Study Type:

Observational

Anticipated Enrollment :

50 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Early Follicular Phase Androstenedione Monitoring During Low-dose Step-up Induction of Ovulation in High Responders

Study Start Date :

Dec 1, 2014

Anticipated Primary Completion Date :

May 1, 2015

Anticipated Study Completion Date :

Jun 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
High responder infertile patients Ovarian high responder patients who are being planned for low-dose step-up protocol ovulation induction and intrauterine insemination.

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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