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.
