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

April 4, 2015 updated by: Eser Sefik Ozyurek, Bagcilar Training and Research Hospital

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

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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
      • Istanbul, Turkey, 34200
        • Recruiting
        • Bagcilar Training and Research Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Primary/Secondary Infertile patients (couples); ovarian high response to ovulation induction anticipated; with mild male factor or without any male factor. Hysterosalpingography reveals patent uterine tubes and normal uterine cavity.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood androstenedione and testosterone levels.
Time Frame: within 10-20 days
Patterns of blood androstenedione and testosterone levels with respect to the regular monitoring parameters and relations to secondary outcomes.
within 10-20 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bagcilar Training and Research Hospital

Investigators

  • Study Director: Eser S Ozyurek, MD, Bagcilar Training and Research Hospital
  • Study Chair: Erdal Kaya, Prof Dr, Bagcilar Training and Research Hospital
  • Study Chair: Mustafa U Karacaoglu, MD, Bagcilar Training and Research Hospital
  • Study Chair: Evrim E Kovalak, MD, Bagcilar Training and Research Hospital
  • Study Chair: Erdinc Ergul, MD, Bagcilar Training and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (Anticipated)

May 1, 2015

Study Completion (Anticipated)

June 1, 2015

Study Registration Dates

First Submitted

December 29, 2014

First Submitted That Met QC Criteria

December 30, 2014

First Posted (Estimate)

December 31, 2014

Study Record Updates

Last Update Posted (Estimate)

April 7, 2015

Last Update Submitted That Met QC Criteria

April 4, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BagcilarTRH

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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