polycystic ovary syndrome (PCOS)
Conditions
Interventions
Medications.
Patients will be randomized to receive either Clomiphene citrate or Puregon (Follitropine/ r-FSH) for ovulation induction (A maximum of 3 cycles of treatment will be given for the purpose
Sponsors
VU University Medical Center, Devision of Reproductive Medicine
Eligibility
Inclusion criteria
Inclusion criteria: The diagnosis of PCOS will be made when a history of at least 6 months inability to conceive is accompanied by at least 2 of the following: 1. Irregular menstruation (oligo- or amenorrhea)(>35 days); 2. Clinical or biochemical evidence of hyperandrogenism (hirsutism, acne, raised TT or FAI); 3. Typical features of PCO on U/S examination (see The Rotterdam Consensus for further details); - All women desiring pregnancy who conform to the definition of PCOS cited above and who have had no fertility treatment in the preceding year; - Age <40 years; - Patients who have previously conceived either spontaneously or on CC therapy may also be included; - Patients with a previous history of pregnancy, whether resulting in a delivery or spontaneous abortion, a previous history of gynecological or abdominal surgical intervention or pelvic inflammatory disease, should have a normal uterine cavity and tubal patency demonstrated by radiological (HSG), laparoscopic or ultrasonic means before entering the study; - A mandatory sperm count deemed normal by the treating physician is acceptable for inclusion. Intrauterine insemination may be employed at the discretion of the treating physician.
Exclusion criteria
Exclusion criteria: 1. Age >39; 2. An obvious mechanical or male factor; 3. Co-existing conditions such as overt diabetes mellitus, oestrogen dependent tumours, ovarian cysts, hypertension, thyroid disease, Cushing’s syndrome or congenital adrenal hyperplasia.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Pregnancy rate – per patient, per cycle, cumulative over 3 cycles (hCG measurement 15 days after ovulation); 2. Miscarriage rate – embryonic, fetal (diagnosed with ultrasound); 3. Multiple pregnancy rate (number of gestational sacs measured with ultrasound); 4. Live birth rate; 5. Ovulation rate (followed with ultrasound); 6. Initiation of treatment to pregnancy interval. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Number and size of follicles >10mm on day of hCG; 2. Endometrial thickness on day of hCG; 3. Estradiol and progesterone concentrations on day of hCG; 4. Number of abandoned cycles (hCG witheld) due to overstimulation or lack of response; 5. Ovarian hyperstimulation; 6. Correlation of basal hormone concentrations with pregnancy and miscarriage rates; 7. Number of units of Puregon used per cycle and per pregnancy achieved. | — |
Contacts
Public ContactR. Homburg
VU Univeristy Medical Center, Department of Obstetrics and Gynaecology, Division of Reproductive Medicine, P.O. Box 7057
Outcome results
None listed