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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	13 April 2015
Main ID:	NCT02329483
Date of registration:	29/12/2014
Prospective Registration:	No
Primary sponsor:	Bagcilar Training and Research Hospital
Public title:	Monitoring the Early Follicular Phase With Androstenedione in Low-dose Step-up Ovulation Induction in High Responders
Scientific title:	Early Follicular Phase Androstenedione Monitoring During Low-dose Step-up Induction of Ovulation in High Responders
Date of first enrolment:	December 2014
Target sample size:	50
Recruitment status:	Recruiting
URL:	http://clinicaltrials.gov/show/NCT02329483
Study type:	Observational
Study design:	Observational Model: Cohort, Time Perspective: Prospective
Phase:	N/A

Countries of recruitment
Turkey

Contacts

Name:	Erdal Kaya, Prof Dr
Address:
Telephone:
Email:
Affiliation:	Bagcilar Training and Research Hospital

Name:	Mustafa U Karacaoglu, MD
Address:
Telephone:
Email:
Affiliation:	Bagcilar Training and Research Hospital

Name:	Eser S Ozyurek, MD
Address:
Telephone:	+905309322345
Email:	eozyurek@yahoo.com
Affiliation:

Name:	Eser S Ozyurek, MD
Address:
Telephone:	+905309322345
Email:	eozyurek@yahoo.com
Affiliation:

Name:	Erdinc Ergul, MD
Address:
Telephone:
Email:
Affiliation:	Bagcilar Training and Research Hospital

Name:	Eser S Ozyurek, MD
Address:
Telephone:
Email:
Affiliation:	Bagcilar Training and Research Hospital

Name:	Evrim E Kovalak, MD
Address:
Telephone:
Email:
Affiliation:	Bagcilar Training and Research Hospital

Key inclusion & exclusion 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

Age minimum: 20 Years
Age maximum: 40 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Ovarian Hyperstimulation Syndrome

Infertility

Intervention(s)

Primary Outcome(s)

Blood androstenedione and testosterone levels. [Time Frame: within 10-20 days]

Secondary Outcome(s)

Pregnancy [Time Frame: 20-30 days]

Ovarian hyperstimulation [Time Frame: 10-30 days]

Cycle cancellation [Time Frame: within 10-20 days]

Need for dose step-up [Time Frame: 7-14 days]

Secondary ID(s)

BagcilarTRH

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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