Clinical trial NCT02329483: Monitoring the Early Follicular Phase With Androstenedione in Low-dose Step-up Ovulation Induction in High Responders
Official title: Early Follicular Phase Androstenedione Monitoring During Low-dose Step-up Induction of Ovulation in High Responders
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Infertility
Ovarian Hyperstimulation Syndrome
Keywords: Infertility
Ovulation induction
Low-dose step-up protocol
Ovarian high responder
Androgens
Androstenedione
Testosterone
rhFSH
Lead sponsor: Bagcilar Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2014-12-31
Enrollment: 50
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility 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

Primary outcomes:
measure: Blood androstenedione and testosterone levels.
timeFrame: within 10-20 days
Secondary outcomes:
measure: Pregnancy
timeFrame: 20-30 days
measure: Cycle cancellation
timeFrame: within 10-20 days
measure: Ovarian hyperstimulation
timeFrame: 10-30 days
measure: Need for dose step-up
timeFrame: 7-14 days
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bagcilar Training and Research Hospital
Study officials:
affiliation: Bagcilar Training and Research Hospital
name: Eser S Ozyurek, MD
role: STUDY_DIRECTOR
affiliation: Bagcilar Training and Research Hospital
name: Erdal Kaya, Prof Dr
role: STUDY_CHAIR
affiliation: Bagcilar Training and Research Hospital
name: Mustafa U Karacaoglu, MD
role: STUDY_CHAIR
affiliation: Bagcilar Training and Research Hospital
name: Evrim E Kovalak, MD
role: STUDY_CHAIR
affiliation: Bagcilar Training and Research Hospital
name: Erdinc Ergul, MD
role: STUDY_CHAIR
References:
citation: Ozyurek ES, Yoldemir T, Artar G. Androstenedione response to recombinant human FSH is the most valid predictor of the number of selected follicles in polycystic ovarian syndrome: (a case-control study). J Ovarian Res. 2017 May 12;10(1):34. doi: 10.1186/s13048-017-0330-7.