Effect of Different Ovarian Stimulation Protocols on Endometrial Receptivity

• Status: Recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

This study will assess the change in endometrial gene expression signature on the day of embryo transfer according to the type of exogenous gonadotropins administered.

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

Details

• Lead Sponsor: Instituto Valenciano de Infertilidade de Lisboa
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Follicle Stimulating Hormone

Criteria

Inclusion Criteria:

1. Informed consent form (ICF) dated and signed.

2. Age: ≥18 and <40 years old.

3. AFC ≥5 and <20.

4. AMH ≥1.1 ng/mL and <2.5 ng/mL, performed in the 12 months prior to inclusion.

5. Body Mass Index (BMI): ≥18.5 Kg/m2 and <30 Kg/m2.

6. Weight: ≥50 kg and <80 kg.

7. First or second ART cycle or fertility preservation cycle.

8. Regular menstrual cycles (between 22 and 35 days).

9. Two ovaries present.

10. Pregnancy-wish.

11. Planned for single blastocyst transfer.

Exclusion Criteria:

1. Simultaneous participation in another clinical study.

2. Previous history of poor ovarian response (<4 oocytes retrieved) with a maximal dose of OS (≥300 IU/day) or OHSS, regardless of gonadotropin dose.

3. Known reasons for impaired implantation (i.e. hydrosalpinx, fibroid distorting the endometrial cavity, Asherman's syndrome, thrombophilia or endometrial tuberculosis).

4. Repeated miscarriages (>2 previous biochemical pregnancies or >2 spontaneous miscarriages).

5. Recurrent implantation failure (>3 failed cycles with good quality embryos).

6. Polycystic ovary syndrome (PCOS).

7. Tumours of the ovary, breast, uterus, pituitary or hypothalamus.

8. Abnormal (not menstrual) vaginal bleeding without a known/diagnosed cause.

9. Ovarian cysts or enlarged ovaries.

10. Fibroid tumours of the uterus incompatible with pregnancy.

11. Malformations of the reproductive organs incompatible with pregnancy.

12. Primary gonadal failure.

13. Renal impairment defined as estimated glomerular filtration rate of 90 ml/min/1.73 m2 determined by the Modified Diet and Renal Disease (MDRD) equation at screening.

14. Previous antibiotic hypersensitivity reactions (streptomycin and/or neomycin).

15. Risk factors for thromboembolic events, such as a personal or family history, severe obesity or thrombophilia.

16. Moderate or severe hepatic impairment.

17. Untreated and uncontrolled thyroid dysfunction.

18. Current use of oral contraceptive, anti-depressants, anti-psychotics, steroids, anti-epileptics or chemotherapy.

19. Administration of exogenous Estradiol (E2), Progesterone (P4) or gonadotropins in the preceding menstrual cycle.

20. Active female smoking.

21. Acceptors of donated oocytes/embryos.

22. Ongoing pregnancy.

23. Women who have previously enrolled in the trial.

24. Those unable to comprehend the investigational nature of the proposed study.