Comparing IVF/ICSI Cycle Outcomes of Post Ovulation Ovarian Stimulation Protocol With Elonva Without GnRH Antagonist to Follicular Phase Day 2 Stimulation Fixed Day 5 Antagonist Protocol

ART Fertility Clinics LLC

Status: Not yet enrolling

Conditions: Stimulation in the Ovary; IVF Outcome

Treatments: Other: Ovarian stimulation with menstruation or after ovulation

Study type: Observational

Funder types: Other

Identifiers

NCT06879002

2409-ABU-015-MF

Details and patient eligibility

About

There are several approaches to the timing of antagonist administration in IVF/ICSI cycles. The primary goal is indeed to prevent premature ovulation, which could jeopardize the success of the cycle There is an emerging concept that suggests that the progesterone produced by the corpus luteum (formed after ovulation) might be sufficient to prevent further ovulation, obviating the need for antagonist or exogenous progesterone administration. This hypothesis relies on the natural regulatory mechanisms of the menstrual cycle to maintain a progesterone-dominated environment post-ovulation. We hypothesized that this approach would minimize treatment costs /burden without having an impact on the outcome.

Enrollment: 252 estimated patients

Sex: Female

Ages: 18 to 38 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age 18 to 38 years old.
• Normal Menstrual cycle of 25-35 days.
• Body Weight 60to90 kg
• AMH>1.3 - <3 ng/m (Ferraretti and Gianaroli, 2014; Calzada et al., 2019) an antral follicle count (AFC) of >5 on menstrual cycle days 2-3,

Exclusion criteria

• History of premature ovulation
• Azoospermia
• PCOS
• Endometriosis AFS ¾
• Endometrioma
• Known chromosomal abnormalities

Trial design

252 participants in 2 patient groups

Group A: - Follicular phase start of ovarian stimulation with Elonva

Description:

Patients considered for ovarian stimulation for IVF/ICSI will be informed and a CF will be given on the day of planning for IVF. In group one, the ovarian stimulation protocol would follow a fixed GnRH antagonist protocol with recombinant FSH, Corifolitropin alfa (Elova150 mcg) starting on day 2 of the menstrual cycle. Group A: Day 2-3 of cycle: Estradiol, Progesterone, Luteinizing Hormone, Follicle stimulating hormone During stimulation: on day 8 of stimulation: Estradiol, Progesterone, Luteinizing Hormone, Follicle stimulating hormone on trigger day: Estradiol, Progesterone, Luteinizing Hormone, Follicle stimulating hormone Final oocyte maturation will be administered when 3 follicles reach 17mm or more. Oocyte retrieval will be performed 36 hours after human chorionic gonadotropin (hCG5000 or 10000IU, choriomon, IBSA) plus GnRH-a (0.2 or 0.3 mg Gonapeptyl, Ferring) administration under transvaginal ultrasound guidance.

Treatment:

Other: Ovarian stimulation with menstruation or after ovulation

Group B: One day after the Positive LH kit test at home: E2 P4 LH FSH,BHCG

Description:

. In group two, Elona 150mcg is being administered after ovulation confirmation with home LH kits starting to be used around usual ovulation days, and be confirmed in clinic with LH rise, E2 drop and blood P4 more than 1ng/dl one day after LH kit is positive. The probability of spontaneous pregnancy will be ruled out by betaHCG test. In case a spontaneous pregnancy has been confirmed,we will not start the treatment . Furthermore, in case of sustained progesterone rise,repeated hCG tests will be performed throughout the stimulation cycle to monitor whether there is an early pregnancy or not. If so,the treatment will be cancelled/stopped to prevent the potential risks of stimulation medications during an early pregnancy.From stimulation Day 8 onwards, hormonal stimulation will continue with daily dose. The maximum injection dose for continuing treatment after the first 7 days will be 200 IU. (10) Final oocyte maturation will be administered when 3 follicles reach 17mm or more.

Treatment:

Other: Ovarian stimulation with menstruation or after ovulation