Status:
COMPLETED
Gonadotrophin Dosage Using a Threshold Nomogram for Ovulation Induction in WHO Group II Anovulatory Infertility
Lead Sponsor:
Rigshospitalet, Denmark
Collaborating Sponsors:
Holbaek Sygehus
Conditions:
Anovulation
Infertility
Eligibility:
FEMALE
18-39 years
Phase:
PHASE4
Brief Summary
Ovulation disorders are a common cause of infertility in women. Most of these women can be classified as World Health Organization (WHO) Group II anovulatory patients as they have irregular or absent ...
Eligibility Criteria
Inclusion
- Anovulatory infertility
- Age 18 - 39 years
- Anovulation with oligomenorrhoea (\> 35 days of mean cycle length) or amenorrhoea
- Normal serum FSH (\< 10 IU/l)
- Two ovaries
- BMI \< 35
- First FSH/HMG cycle at the Fertility clinic.
- A sperm sample compatible with conception or semen from a donor.
- Tubal patency documented by either hysterosalpingography (HSG) or hysterosalpingography by ultrasound (HSU) in cases where the woman has had a pelvic infection or pelvic surgery.
Exclusion
- A history of \>12 ovulation induction cycles without achieving pregnancy.
- More than three earlier gonadotropin cycles at other clinics or earlier treatments with threshold doses below 75.
- Known hyperprolactinaemia or any other endocrine disturbance or systemic disease of the pituitary gland, thyroid gland, adrenal gland, pancreas, liver or kidney.
- Undiagnosed vaginal bleeding.
- Acute or chronic infection with HIV or hepatitis.
- Persistent ovarian cysts or endometriomas detected by ultrasound.
- Tumors of the hypothalamus, pituitary gland, breast, adrenal gland or ovary.
- Pregnancy or lactation.
- Current or past alcohol or drug abuse.
- A history of chemo- or radiotherapy.
- Malformations of reproductive organs incompatible with pregnancy.
- Hypersensitivity to any trial medication.
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT01250821
Start Date
December 1 2010
End Date
April 1 2013
Last Update
April 19 2013
Active Locations (1)
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1
The Fertility Clinic, Section 4071, Rigshospitalet
Copenhagen, Denmark, DK-2100