| Eligibility |
Inclusion Criteria:
- Women = 18 to = 40 years of age, with one or more years infertility history, desirous
of conceiving, regularly ovulating (defined as 9 or more menses per year), at
initiation of participation.
- BMI = 30 kg/m2 obtained at screening visit.
- Normal uterine cavity and at least one open fallopian tube confirmed by
hysterosalpingography (HSG), sonohysterography (SHG), or laparoscopy/hysteroscopy in
the last three years preceding enrollment into the study. An uncomplicated
intrauterine non-IVF pregnancy and uncomplicated delivery and postpartum course
resulting in live birth within the last three years will also serve as sufficient
evidence of a patent tube and normal uterine cavity as long as the subject did not
have, during the pregnancy or subsequently, risk factors for Asherman's syndrome or
tubal disease or other disorder leading to an increased suspicion for intrauterine
abnormality or tubal occlusion.
- Evidence of ovarian function/reserve as assessed by day 3 (+/-2 days) FSH = 10 IU/L
with Estradiol = 70 pg/mL OR AMH = 1 ng/mL within one year prior to study initiation.
- Normal or corrected thyroid function within one year of study initiation.
- Normal or corrected prolactin level within one year of study initiation.
- In general good health, not taking any medications which could interfere with the
study (e.g., FSH, insulin sensitizers).
- Ability to have inseminations following hCG administration
- Male partner with total motile sperm in the ejaculate of at least 5 million sperm,
within one year of study initiation
- Able to comply with intercourse instructions and collection of semen for insemination
- Anyone enrolled and randomized to the RMN FIT PLESE study
Exclusion Criteria:
- Currently pregnant or successful pregnancies within 12 months of initiating
participation. Clinical intrauterine miscarriages prior to initiating participation,
within ASRM guidelines: subjects over 35 must wait six months, while subjects under 35
must wait 12 months. No exclusion for biochemical pregnancies.
- Undiagnosed abnormal uterine bleeding.
- Suspicious ovarian mass.
- Subjects on oral contraceptives, depo-progestins, or hormonal implants (including
Implanon). A two month washout period will be required prior to screening for patients
on these agents. Longer washouts may be necessary for certain depot contraceptive
forms or implants, especially when the implants are still in place. A one-month
washout will be required for patients who have taken oral cyclic progestins.
- Known 21-hydroxylase deficiency or other enzyme defect causing congenital adrenal
hyperplasia.
- Type I or Type II diabetes mellitus, or if receiving antidiabetic medications.
- Known significant anemia (Hemoglobin <10 g/dL).
- History of deep venous thrombosis, pulmonary embolus, or cerebrovascular event.
- Known heart disease (New York Heart Association Class II or higher).
- Known liver disease (defined as AST or ALT >2 times normal, or total bilirubin >2.5
mg/dL).
- Known renal disease (defined as BUN >30 mg/dL or serum creatinine > 1.4 mg/dL).
- History of, or suspected cervical carcinoma, endometrial carcinoma or breast
carcinoma.
- History of alcohol abuse (defined as >14 drinks/week) or binge drinking of = 6 drinks
at one time).
- Known Cushing's disease.
- Known or suspected adrenal or ovarian androgen secreting tumors.
- Allergy, known hypersensitivity or contraindication to the treatment medications used
in this study including clomiphene citrate (previous change in vision).
- Couples with previous sterilization procedures (e.g. vasectomy, tubal ligation)
whether or not it has been reversed.
- Subjects with untreated poorly controlled hypertension defined as a systolic blood
pressure = 160 mm Hg or a diastolic = 100 mm Hg obtained on two measures obtained at
least 60 minutes apart.
- Subjects who have undergone a bariatric surgery procedure in the past or are in a
period of acute weight loss (defined as a weight loss of greater than 5 kgs in the
last 6 months).
- Known moderate or severe endometriosis
- Anovulation or oligo-ovulation including hypothalamic amenorrhea, polycystic ovary
syndrome, etc.
- Donated semen.
- Couples in which either partner is legally married to someone else.
- Medical conditions that are contraindications to pregnancy.
- Presence of severe, untreated psychiatric illness (major depression, substance abuse,
eating disorder, etc.) that would, in the opinion of the site investigator, interfere
with the patient's ability to successfully complete the study.
- Currently participating in a lifestyle intervention program (such as Weight Watchers,
Atkins Diet, Curves) or lost more than 5% body weight within the last 6 months.
- History of Gout.
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