Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase 3, Single-Blind, Randomized Study to Compare DR-2011 to a Progesterone Gel for Luteal Phase Supplementation for In Vitro Fertilization
Brief Summary: This is a multi-center study to evaluate the effects of DR-2011 compared to a progesterone gel in women undergoing in vitro fertilization with fresh eggs. The overall study duration will be approximately 12 months and will involve ovarian suppression/stimulation protocols as well as egg retrieval.


Options:
A: Inclusion Criteria:

* Age 18- 42 (upon starting COH);
* BMI \<30 kg/m2;
* \<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 polyp or protruding sub-mucosal fibroid);
* At least 3 retrieved oocytes;
* Patient has given written informed consent.

Exclusion Criteria:

* Intramural uterine fibroids that distort the uterine cavity or polyps \>1 cm;
* Stage III or IV endometriosis (endometriomas);
* Hydrosalpinx;
* History of past poor response to COH resulting in canceling ART;
* Use of thawed/donated oocytes;
* Use of thawed/donated embryos;
* Patients affected by pathologies associated with any contraindication of being pregnant;
* Hypersensitivity to study medication;
* Uncontrolled adrenal or thyroid dysfunction;
* Undiagnosed vaginal bleeding;
* History of arterial disease;
* Patients with hepatic impairment;
* Neoplasias (current) or history of neoplasia that may be responsive to progesterone;
* High grade cervical dysplasia;
* Active thrombophlebitis or thromboembolic disorders, or a history of hormone-associated thrombophlebitis or thromboembolic disorders;
* 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 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:

* routine ovulation induction protocol with GnRH agonist
* less than three prior IVF cycles
* at least three aspirated oocytes
* BMI \<35 kg/m2
* age \<45 years

Exclusion Criteria:

* history of dysfunctional uterine bleeding
* acute urogenital disease
* recurrent miscarriage
* previous allergic reactions to a progesterone products
C: Inclusion Criteria:

1. Patients who underwent ovarian stimulation using GnRH analogues,
2. Fresh embryo transfer,
3. LPS by vaginal micronized P4,
4. Clinical pregnancy demonstrated by US and
5. Informed consent signed.

Exclusion Criteria:

Patients who had bleeding episodes before their first US because they are likely to continue P4 therapy without medical indication.
D: Inclusion Criteria:

* Pre-menopausal, aged 18-42 old at time of consent
* At least one cycle without fertility medication prior to screening
* Tubal, idiopathic, male factor, ovulatory dysfunction or endometriosis- linked infertility
* Semen analysis (frozen sperm, including donor sperm, may be used, as long as testing done at time of freezing meets standard criteria)
* Others as indicated by FDA-approved protocol

Exclusion Criteria:

* Any contraindication to progesterone therapy
* BMI \> 38 kg/m2
* Clinically significant gynecologic pathology (for example: submucosal fibroids, abnormal uterine cavity, or others)
* History of more than 1 failed fresh IVF cycles
* More than 2 consecutive clinical miscarriages (gestational sac observed on ultrasound)
* Others as indicated by FDA-approved protocol

Answer: D