Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06235294 |
| Other study ID # |
RA-01-23 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 2024 |
| Est. completion date |
December 2025 |
Study information
| Verified date |
January 2024 |
| Source |
Centro Hospitalar e Universitário de Coimbra, E.P.E. |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The goal of this randomized, double-blind, placebo-controlled clinical trial is to verify if
3-month oral supplementation with resveratrol can enhance the oocyte quality in advanced
maternal age women undergoing in vitro fertilization (IVF).
Participants will take a daily capsule of resveratrol or placebo during the 3 months
preceding their IVF treatment. They will then follow the same treatment protocol as
non-participant patients.
Description:
The study will be conducted in the Reproductive Medicine Unit of an Academic Hospital.
Eligible participants who meet the inclusion and exclusion criteria will be randomly assigned
to one of the following groups:
1. Resveratrol (study group) or
2. Placebo (control group).
Supplementation
Women in the study group will take a daily capsule of 200 mg Polygonum cuspidatum (Solgar®,
Dietimport, Lisboa, Portugal) yielding 100 mg/day resveratrol
(trans-3,5,4'-trihydroxystilbene). Women from control group will take a daily capsule of 400
mcg folic acid (Solgar®, Dietimport, Lisboa, Portugal), a vitamin widely prescribed to women
who intend to achieve pregnancy for prevention of neural tube defects). Participants will be
instructed to take the capsules by morning, every day during the 3 months preceding their IVF
treatment. Oral intake of resveratrol/placebo will be discontinued after oocyte retrieval due
to the potential adverse effects of resveratrol on endometrial decidualization. Package of
resveratrol and placebo will be identical. Compliance of the participant to the intervention
will be measured using capsule count. Participants will be asked to keep their usual
lifestyle including nutrition and physical activity level.
Ovarian stimulation
GnRH antagonist protocol will be used in all the patients. On day 2 or 3 of the menstrual
cycle, daily subcutaneous (SC) injections of rFSH are given up to the day of human chorionic
gonadotropin (hCG) administration, when at least three leading follicles reached a mean
diameter of 17 mm. Doses of rFSH range from 150 to 300 IU/day depending on the women's age,
body mass index (BMI), AFC and AMH. Administration of a daily dose of 0.25 mg of gonadotropin
releasing hormone antagonist (GnRHa) (Cetrotide ®, Merck, Netherlands; or Orgalutran ®,
Organon, Netherlands) is initiated when the larger follicle reaches a mean diameter of 14 mm.
Transvaginal oocyte retrieval is scheduled to 36 hours after choriogonadotropin alfa (α-hCG)
administration. Luteal phase support with progesterone is initiated on the day of the oocyte
retrieval with 200 mg of micronized intravaginal progesterone every 8 hours (Progeffik ®,
EFIKK, France).
In vitro fertilization and embryo transfer
According to the couples's indication, IVF or ICSI is performed. Fertilization is assessed
after 18 hours, and oocyte maturational stage is assessed and registered. Embryo cleavage is
assessed every 24 hours. Embryo transfer is performed 5 days after oocyte retrieval under
ultrasound guidance. All remaining good quality embryos will be vitrified and transferred in
subsequent menstrual cycles. If fresh transfer is canceled for clinical reasons, frozen
embryo transfer will also be scheduled. Before frozen embryo transfer, patients will start
exogenous hormone therapy for endometrial preparation. This therapy is initiated on day 1 of
menstrual cycle and consists of 150 mcg of estradiol transdermal patches (Dermestril®, BGP,
Lisboa, Portugal) replaced every 3 days. On day 12-14, a pelvic ultrasound is performed to
assess endometrial development. If the endometrial thickness is > 7 mm, 400 mg vaginal
micronized progesterone (Cyclogest®, Gedeon Richter, Budapest, Hungria) twice daily was added
to the treatment scheme. Fourteen days after oocyte retrieval a quantitative serum value of
β-hCG is obtained and a transvaginal ultrasound is scheduled one week later in case of a
positive result (biochemical pregnancy). Clinical pregnancy is established by the
ultrasonography visualization of a gestational sac. Ongoing pregnancy was defined by a viable
intrauterine pregnancy of at least 12 weeks duration confirmed on an ultrasound scan. The
outcomes of fresh and vitrified-warmed embryo transfer will be analyzed. Live birth was
defined as the delivery of one or more live babies. Miscarriage was defined by a spontaneous
pregnancy termination before the gestational age of 12 weeks.
