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

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ClinicalTrials.gov Identifier: NCT02329483
Recruitment Status : Unknown
Verified April 2015 by Eser Sefik Ozyurek, Bagcilar Training and Research Hospital.
Recruitment status was:  Recruiting
First Posted : December 31, 2014
Last Update Posted : April 7, 2015
Sponsor:
Information provided by (Responsible Party):
Eser Sefik Ozyurek, 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.

Condition or disease
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.

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Study Type : Observational
Estimated 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 : December 2014
Estimated Primary Completion Date : May 2015
Estimated Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility

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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Pregnancy [ Time Frame: 20-30 days ]
    blood hCG level >10mIU/mlt

  2. Cycle cancellation [ Time Frame: within 10-20 days ]
    cancellation of treatment despite 2 rounds of dose step-up

  3. Ovarian hyperstimulation [ Time Frame: 10-30 days ]
    Enlarged ovaries, abdominal ascites, pleural effusion, hemoconcentration, abdominal swelling

  4. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02329483


Contacts
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Contact: Eser S Ozyurek, MD +905309322345 eozyurek@yahoo.com

Locations
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Turkey
Bagcilar Training and Research Hospital Recruiting
Istanbul, Turkey, 34200
Contact: Eser S Ozyurek, MD    +905309322345    eozyurek@yahoo.com   
Contact: Mustafa U Karacaoglu, MD       dr.uner@hotmail.com   
Sponsors and Collaborators
Bagcilar Training and Research Hospital
Investigators
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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 automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Eser Sefik Ozyurek, Operator Doctor, Bagcilar Training and Research Hospital
ClinicalTrials.gov Identifier: NCT02329483    
Other Study ID Numbers: BagcilarTRH
First Posted: December 31, 2014    Key Record Dates
Last Update Posted: April 7, 2015
Last Verified: April 2015
Keywords provided by Eser Sefik Ozyurek, Bagcilar Training and Research Hospital:
Infertility
Ovulation induction
Low-dose step-up protocol
Ovarian high responder
Androgens
Androstenedione
Testosterone
rhFSH
Additional relevant MeSH terms:
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Infertility
Ovarian Hyperstimulation Syndrome
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases