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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Page 1 of 1 (1 locations)

1

The Fertility Clinic, Section 4071, Rigshospitalet

Copenhagen, Denmark, DK-2100