How do different ovarian stimulation protocols affect endometrial receptivity during a fresh in vitro fertilization attempt?

Phase 1

• Conditions: Women with a clinical indication to undergo Assisted Reproductive Technologies for infertility with a predicted normal response to Ovarian Stimulation and planned for a single blastocyst transfer; Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

• Registration Number: EUCTR2018-003556-20-PT
• Lead Sponsor: INSTITUTO VALENCIANO DE INFERTILIDADE - CLÍNICA DE REPRODUÇÃO ASSISTIDA, LDA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-04-30
• Last Update Posted: 12 March 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 24

Inclusion Criteria

1. Informed consent form (ICF) dated and signed.
2. Age: =18 and <40 years old.
3. Antral follicular count (AFC): =5 and <20.
4. Anti-Müllerian Hormone (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 Assisted Reproductive Technologies (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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 24
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 Ovarian hyperstimulation syndrome (OHSS), regardless of gonadotropin dose.
3. Known reasons for impaired implantation (specifically 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), 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified