A Study to assess the Efficacy and Safety of Estradiol hemihydrate Tablet 2mg Vs Estradiol Valerate Vs Estradiol hemihydrate Tablet (2 mg) plus Estradiol TG (Topical Gel) in Patients who are going for invitro fertilizatio

Phase 3

• Conditions: Health Condition 1: O090- Supervision of pregnancy with history of infertility

• Registration Number: CTRI/2024/06/069694
• Lead Sponsor: Dr Kundan Ingale

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Female patients of = 21 and =43years of age at the time of consent

2. Female patients who are eligible for frozen embryo transfer FET

3. Female patients who can and willing to provide written Informed Consent

4. Female patients who had at least two top-quality blastocysts appropriate for cryopreservation

Top-quality blastocysts were defined as day-5 embryos with well-formed structures, including a prominent inner cell mass and a trophectoderm, exhibiting optimal expansion and minimal fragmentation

5. Female patients / patients’ legally acceptable representative understands and can comply with clinical trial protocol requirements

Exclusion Criteria

1. Female patients undergoing donor oocyte treatment.

2. Female patients with endocrine or metabolic disorder

3. Female patients with any underlying diseases (kidney, liver or heart diseases)

4. Female patients with a history of Thrombosis in any part of the body (Deep vein thrombosis, Pulmonary Embolism, etc.)

5. Female patients who are allergic to the estrogen supplementation or any of its ingredients

6. Female patients with bad quality blastocysts.

7. Female patients with Endometrium thickness less than 7.5mm and more than 14mm.

8. Female patients with known ART failures that warrants no further ART program feasible

9. Female patients who have participated in another trial with an investigational drug within 3 months prior to this trial.

10. Female patients who, in the judgment of the investigator, will be unlikely to comply with the requirements of this protocol

11. Female patients with any other clinically significant illness

12. Female Patients with Intra Uterine Pathologies like Fibroid, Polyp, etc.

13. Female Patients with Hydro Salpinx

Study & Design

• Study Type: Interventional
• Study Design: Not specified