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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05972902
Other study ID # Dydrogesterone IVF
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date July 15, 2023
Est. completion date December 31, 2023

Study information

Verified date August 2023
Source Beni-Suef University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To compare the effects of Duphaston compared to GnRH agonist and antagonist on the prevention of premature LH surge and quality of retrieved oocytes and embryos in women undergoing intra-cytoplasmic sperm injection.


Description:

Study Design: A randomized clinical trial (RCT). Study Site: The study will be conducted at Beni-Suef University Hospital Assisted Reproductive Techniques center. The study population includes all infertile women undergoing IVF at Beni-Suef University ART center will be included. Women will be recruited for enrollment when they come to fertility clinic and scheduled for ICSI trial. They will be counseled and asked to participate in the study after been evaluated to ensure fulfilling inclusion and exclusion criteria. Study Sample: The study consisted of 387 women which will be randomized into 3 groups. Women will be enrolled in the study after giving written informed consent. Group (A): 129 Women will start Dydrogesterone group. Group (B): 129 Women will undergo Agonist protocol group. Group (c): 129 Women will undergo Antagonist protocol group. Study Procedure: Full history taking. Systematic clinical examination to assess the general condition, body mass index (BMI) and local pelvic physical findings and AFC by trans-vaginal ultrasound on D2 to 3 of menstruation. Routine labs as CBC, liver & kidney functions to exclude general disease as a contraindication for induction or pregnancy. Blood sample obtained for assessment of basal serum levels of FSH, LH, PRL, AMH and E2 on day 3 of the cycle. Ovarian Stimulation: #Treatment protocols: The patients begins injections of recombinant FSH (rFSH, Gonal-F; Merck- Serono, Italy) or human menopausal gonadotropin (hp-hMG, Menopur; Ferring Pharmaceuticals, Geneva,Switzerland) since day 2-3 of menstruation, with daily dose of 150-450 IU adjusted according to individual conditions on the basis of the antral follicle count (AFC), age of the woman, body mass index (BMI), and previous ovarian response, according to the standard operating procedures of the center. For pituitary suppression, the patients received: - Dydrogesterone (Duphaston 10 mg/twice daily, Abbott Healthcare, America) orally since day 2-3. - GnRH antagonist (CETROTIDE 0.25MG , MERCK SERONO, Germany) 0.25 mg/day subcutaneously since the dominant follicles reached the diameter of 12-14 mm till trigger day. - GnRH agonist (Decapeptyl, sc 0.1 mg/day) beginning in the afternoon of the 21st day of the cycle prior to stimulation. The serum LH, estradiol and progesterone levels as well as number and size of follicles will be monitored every 1 to 2 days, starting from stimulation day 5 until the day of hCG injection. The daily dose of rFSH will be adjusted according to patient' s ovarian response, based on serum estradiol levels and the number and size of ovarian follicles as measured by transvaginal ultrasonography. Triggering and Ovum pick uptake: Triptorelin (0.2 mg; Decapeptyl, Ferring Pharmaceuticals, the Netherlands) or human chorionic gonadotropin (10000 IU; Choriomon) or Ovitrel 250 mg (Merck Serono, Italy) are given to trigger final maturation of the oocytes. Oocyte retrieval was performed approximately 36 hours later. Fresh and Frozen Embryo Transfer: A maximum of 2 embryos will be transferred on day 3 after retrieval under transabdominal ultrasound guidance. Day 3 -5 embryos in the antagonist group and all the viable embryos or blastocysts in the duphaston group are cryopreserved using vitrification.


Recruitment information / eligibility

Status Recruiting
Enrollment 387
Est. completion date December 31, 2023
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 40 Years
Eligibility Inclusion Criteria: - Having indications for ICSI. Exclusion Criteria: 1. Any known contraindications to the approved fertility drugs. 2. Severe endometriosis. 3. Uterine malformations or abnormal uterine cavity. 4. Uncontrolled endocrinopathies: DM, hyperthyroidism, hypothyroidism. 5. Severe male factor for infertility.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Dydrogesterone
Dydrogesterone molecular structure and pharmacologic effects are closely related to endogenous progesterone
Cetrorelix acetate
GnRH antagonist
Triptorelin
GnRH agonist

Locations

Country Name City State
Egypt Beni-suef university Hospital Bani Suwayf Beni Suef

Sponsors (1)

Lead Sponsor Collaborator
Beni-Suef University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of oocytes retrieved. number of oocytes 1cycle (1 month)
Primary maturity of oocytes retrieved. either M2 or M1 1 cycle (1month)
Secondary Duration of stimulation days till trigger 1 ICSI cycle (1 month)
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