Health Condition 1: O090- Supervision of pregnancy with history of infertility
Conditions
Interventions
Intervention1: Estradiol hemihydrate Tablet (2 mg) + Estradiol TG (Topical Gel): One tablet thrice a day to be taken orally till desired endometrial thickness is achieved (maximum till Day 22) + 2 mea
Sponsors
Dr Kundan Ingale
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1 Implantation rate Implantation rate is defined as the ratio of gestational sacs to the number of embryos transferred. 2 Endometrial thickness Endometrial thickness will be measured as the distance between the two layers of endometrium through transvaginal ultrasound.Timepoint: Implantation rate - (Time point: 4- 5 weeks after embryo transfer through transvaginal ultrasound) Endometrial thickness - (Time points: Visit 2 and Visit 4) | — |
Secondary
| Measure | Time frame |
|---|---|
| Biochemical pregnancy Biochemical pregnancy is defined as a serum ß human chorionic gonadotropin level greater than 25 IU/L 13 days after embryo transferTimepoint: Biochemical pregnancy - Time point - 13 days after embryo transfer;Clinical pregnancy rate Clinical pregnancy will be determined as the presence of a gestational sac with heart beats identified by vaginal or abdominal ultrasound 4-5 weeks after embryo transferTimepoint: Clinical pregnancy rate - Time point - 13 days after embryo transfer;Time taken to reach the desired endometrial thickness (Desired thickness will be 8 mm or as per investigator’s discretion)Timepoint: Time taken to reach the desired endometrial thickness - (Time point: The day desired endometrial thickness is achieved.);Duration of Estrogen TreatmentTimepoint: Duration of Estrogen Treatment - (Timepoint: Will be assessed pre-ET);Ongoing pregnancy rate Ongoing pregnancy is defined as a viable intrauterine pregnancy after 12week of gestationTimepoint: Ongoing pregnancy rate - Time point - after 12week of gestation;Abortion or miscarriage Abortion or miscarriage is defined as a non-viable intrauterine pregnancy after 12week of gestationTimepoint: Abortion or miscarriage - Time point - after 12week of gestation | — |
Countries
India
Contacts
Public ContactMs Shruthi Reddy
Nirmiti Clinic
Outcome results
None listed