Vaginal Compared to Intramuscular Progesterone for Frozen Embryo Transfer

• Status: Completed
• Trial end date: 2018-04-27
• Target enrollment: 0
• Participant gender: Female

Summary

To determine whether the of vaginal progesterone replacement for frozen embryo transfer results in equivalent live birth rates to intramuscular injection progesterone replacement.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shady Grove Fertility Reproductive Science Center
• Collaborator: Ferring Pharmaceuticals
• Treatments: Progesterone

Criteria

Inclusion Criteria:

1. Signed informed consent

2. Female age between 18 and 48 years

3. Having available blastocyst(s) frozen by vitrification method at our center (Shady Grove Fertility).

4. Standard eligibility criteria to undergo frozen blastocyst transfer at Shady Grove Fertility.

Exclusion Criteria:

1. Requires fresh embryos or surrogate carrier

2. Embryos from frozen oocytes and embryos frozen more than once

3. Any embryo cryopreserved by slow freeze method and/or prior to blastocyst stage

4. Presence of any clinically relevant systemic disease contraindicated for ART

5. History of more than 3 failed cycles in previous ART attempts and/or more than 3 recurrent pregnancy losses after ET

6. Surgical or medical condition or requirement for medication, which may interfere with absorption, distribution, metabolism, or excretion of the drugs to be used

7. Subjects with a body mass index (BMI) of <18 or >38 kg/m2 at screening

8. Current or recent substance abuse, including alcohol and tobacco. (Note: Subjects who stopped tobacco usage at least 3 months prior to screening visit will be allowed)

9. Currently breast feeding, pregnant, or having (a) contraindication(s) to pregnancy

10. Refusal or inability to comply with the requirements of the protocol for any reason, including scheduled clinic visits and laboratory tests

11. Trophectoderm or blastomere biopsy of the blastocyst(s) to be transferred.

12. Documented intolerance or allergy to any of the medications used, including the study medication

13. Participation in any experimental drug study within 60 days prior to screening

14. If a subject undergoes more than two frozen blastocyst transfers meeting study criteria, she will only be eligible to enroll in the study for two of these.