Please select the eligibility criteria that correspond to the clinical trial below.
Title: Subcutaneous Progesterone Versus Vaginal Progesterone Gel for Luteal Phase Support in Gonadotropin Ovarian Stimulation for Intrauterine Insemination: a Pilot Randomized Controlled Study
Brief Summary: It is well known that implantation of the developing blastocyst occurs during the luteal phase of the menstrual cycle when the endometrium is under the direct influence of Progesterone (P).Several prospective randomized controlled trials have evaluated the benefits of luteal phase P support in ovulation induction cycles and a recent review and meta-analysis demonstrated that it may be of benefit to patients undergoing ovulation induction with gonadotropins in intrauterine insemination (IUI) cycles. Until now, injectable P was offered only in an oil-base solution owing to the insoluble properties of the molecule, which made the IM route mandatory. A recent publication, however, demonstrated the efficacy of a new P formulation that could be a game changer. The aim of the present pilot trial will be to compare the efficacy and tolerability of 25 mg/d of the new SC P with 90 mg/d of vaginal gel P for luteal phase support (LPS) in COH and IUI cycles.


Options:
A: Inclusion Criteria:

* Patient has given written informed consent;
* BMI \< 30 kg/m2;
* Age 18 - 42 (upon starting COH);
* \<3 prior ART cycles (IVF, ICSI and related procedures);
* Baseline (day 2-3 of cycling) FSH \<15 IU/L and E2 \<80 pg/mL;
* Normal uterine cavity as per recent hysterosalpingogram, sonohysterogram or hysteroscopic exam (i.e. no polyps or protruding submucosal fibroids);
* Patients must have at least three retrieved oocytes.

Exclusion Criteria:

* Intramural uterine fibroids that distort the uterine cavity or polyps \>1 cm;
* Stage III or IV endometriosis (no endometriomas);
* Hydrosalpinges;
* History of past poor response to COH resulting in canceling ART;
* Use of thawed/donated oocytes;
* Use of thawed/donated embryos;
* Gestational carrier;
* Patients affected by pathologies associated with any contraindication of being pregnant;
* Hypersensitivity to study medication;
* Uncontrolled adrenal or thyroid dysfunction;
* History of conditions (i.e. toxic shock syndrome) that would contraindicate use of a vaginal progesterone product;
* History of arterial disease;
* Patients with hepatic impairment (liver function tests \> 2x upper limits of normal);
* Patients with dermatologic disease;
* Patients with renal impairment (estimated creatinine clearance \<60 mL/min/1.73 m2);
* Neoplasias (current) or history of neoplasia that may be responsive to progesterone;
* High grade cervical dysplasia;
* History of recurrent pregnancy loss defined as 3 or more spontaneous miscarriages, wherein pregnancy developed to a minimum of a gestational sac on TVUS;
* Participation in a concurrent clinical trial or in another trial within the past 2 months;
* Use of concomitant medications that might interfere with the study evaluation;
* Pre-implantation genetic diagnosis/screening
B: Inclusion Criteria:

\<38 years of age with either primary or secondary infertility for at least 1 years; body mass index between 19 and 30 kg/m2; Day 2 serum FSH \<15 IU/ml; normal serum prolactin level; normal uterine cavity on hysterosalpingography or hysteroscopy.-

Exclusion Criteria:

female partners with previous ovarian surgery, one ovary, polycystic ovaries on ultrasound examination, other endocrine abnormalities (i.e., polycystic ovarian syndrome, thyroid disorders, hyperprolactinemia, hypogonadotropic hypogonadism), diminished ovarian reserve (basal FSH level \>15 IU/mL), or age of \>38 years
C: Inclusion Criteria:

* Patient complying with the conditions for IVF or ICSI treatment
* Female age over 20 years and under 40 years
* Normal regular cycle and patients with oligomenorrhea
* BMI \> 18 and \< 35
* each patient contributes with one cycle only

Exclusion Criteria:

* Significant disturbances in the woman (diabetes, epilepsy, liver/renal/heart disease, metabolic disorder)
* Patients with \> 25 follicles on the day of triggering ovulation
D: Inclusion Criteria:

* Females of couples with an indication for COH and IVF or ICSI;
* \>=18 and \<=39 years of age at the time of signing informed consent;
* BMI \>=18 and \<=29 kg/m\^2;
* Normal menstrual cycle length: 24-35 days;
* Ejaculatory sperm (use of donated and/or frozen sperm is allowed);
* Willing and able to sign informed consent.

Exclusion Criteria:

* History of/or any current (treated) endocrine abnormality;
* History of ovarian hyperstimulation syndrome (OHSS);
* History of/or current polycystic ovary syndrome (PCOS) or current polycystic ovaries according to USS (at least 10 follicles of 2-8 mm in each ovary);
* More than three unsuccessful COH cycles since the last established ongoing pregnancy (if applicable);
* History of non- or low ovarian response to FSH/hMG treatment;
* Any clinically relevant hormone value outside the reference range during the early follicular phase (menstrual cycle day 2-7) as measured by the local laboratory (FSH, LH, E2, P, total T, TSH and prolactin):
* Any clinically relevant abnormal laboratory value;
* Less than 2 ovaries;
* Any ovarian and/or abdominal abnormality interfering with ultrasound examination;
* Contraindications for the use of gonadotropins (e.g. tumors, pregnancy/lactation, undiagnosed vaginal bleeding, hypersensitivity, ovarian cysts);
* Epilepsy, diabetes, cardiovascular, gastro-intestinal, hepatic, renal, pulmonary, or abdominal disease;
* History of presence of alcohol or drug abuse within 12 months prior to signing informed consent;
* Previous use of Org 36286;
* Use of hormonal preparations within 1 month prior to randomization;
* Hypersensitivity to Org 32489 (Puregon®) and/or Org 37462 (Orgalutran®) and/or Pregnyl® or any of their components;
* Administration of investigational drugs within three months prior to signing informed consent.

Answer: B