Clinical trial NCT05197374: Effect of Estradiol Pretreatment on Antagonist ICSI Cycles
Official title: Studying The Effect of Estradiol Pretreatment on Follicular Synchronization and Intracytoplasmic Sperm Injection (ICSI) Outcome in Antagonist Cycles
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Female Infertility
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2022-01-19
Enrollment: 114
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 37
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Depended on the hypothesis that growth asynchrony of antral follicles is a consequence of the gradual follicle stimulating hormone (FSH) elevation that occurs during the late luteal phase, the aim of this work is to study the effect of estradiol pretreatment on follicular synchronization and intracytoplasmic sperm injection (ICSI) outcome in antagonist cycles

Detailed description: Gonadotropin-releasing hormone antagonist (GnRH-ant) cycles are characterized by higher patient acceptability with more attention being directed to the potential effect of steroid pretreatment to program antagonist protocol cycles, as marked size discrepancies of growing follicles reflect incoordinated maturation of follicular-oocyte complexes and complicates clinical criteria for human chorionic gonadotropin (hCG) administration. This phenomenon is associated with fewer mature oocytes and resulting embryos, which limits sufficient embryo selection for embryo transfer. Indeed, the large number of available embryos represented an important prognostic factor of invitro-fertilization (IVF) outcome, particularly in poor prognosis patients, possibly by increasing the probability that at least one good-quality embryo will be selected for embryo transfer. During COH, a better understanding of follicular development has resulted in the improvement of strategies for ovarian stimulation. This approach represents a potential and more physiological alternative to GnRH agonist or oral contraceptive pills pre-treatment in a trial to synchronize multi-follicular development and improve controlled ovarian hyperstimulation (COH) results. The present study is a randomized controlled trial that investigated whether E2 pre-treatment during the luteal phase affects developmental characteristics of growing follicles during COH. It depended on the hypothesis that growth asynchrony of antral follicles is a consequence of the gradual FSH elevation that occurs during the late luteal phase, thus testing for detection of the effect of luteal estradiol on follicular synchronization and its effect on ICSI outcome.

Eligibility criteria: Inclusion Criteria:

1. Women age 20-37 years.
2. Anti-mullerian (AMH) level greater than 1.2 ng/ml.
3. Body mass index between 18 and 29 kg/m2.
4. Undergoing a first or second ICSI cycles.

Exclusion Criteria:

1. Endometriosis.
2. Uterine disorders such as fibroids and uterine anomalies.
3. Antral follicular counts (AFC) less than 10.
4. Azoospermic males.

Primary outcomes:
measure: Days of stimulation.
timeFrame: 7-16 days after start of controlled ovarian stimulation.
measure: Total number of gonadotropin ampoules used.
timeFrame: 7-16 days after start of controlled ovarian stimulation.
measure: Total number of follicles by U/S on day of hCG.
timeFrame: 7-16 days after start of controlled ovarian stimulation.
measure: Serum estradiol and progesterone level on day of hCG .
timeFrame: 7-16 days after start of controlled ovarian stimulation.
measure: Endometrial thickness on day of hCG.
timeFrame: 7-16 days after start of controlled ovarian stimulation.
measure: Number of mature oocytes
timeFrame: 36 hours after oocyte retrieval.
measure: Number of good quality embryos.
timeFrame: 3 days after oocyte retrieval.
Secondary outcomes:
measure: Pregnancy rate
timeFrame: 14 days after embryo transfer
measure: Clinical pregnancy rate
timeFrame: 2 weeks after positive pregnancy test
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: IVF center
Study officials:
affiliation: Alexandria University
name: Sherif Hebisha, phD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Devreker F, Pogonici E, De Maertelaer V, Revelard P, Van den Bergh M, Englert Y. Selection of good embryos for transfer depends on embryo cohort size: implications for the 'mild ovarian stimulation' debate. Hum Reprod. 1999 Dec;14(12):3002-8. doi: 10.1093/humrep/14.12.3002.
citation: Opsahl MS, Blauer KL, Black SH, Lincoln SR, Thorsell L, Sherins RJ. The number of embryos available for transfer predicts successful pregnancy outcome in women over 39 years with normal ovarian hormonal reserve testing. J Assist Reprod Genet. 2001 Oct;18(10):551-6. doi: 10.1023/a:1011906024170.
citation: Lee H, Choi HJ, Yang KM, Kim MJ, Cha SH, Yi HJ. Efficacy of luteal estrogen administration and an early follicular Gonadotropin-releasing hormone antagonist priming protocol in poor responders undergoing in vitro fertilization. Obstet Gynecol Sci. 2018 Jan;61(1):102-110. doi: 10.5468/ogs.2018.61.1.102. Epub 2017 Dec 19.
citation: Cedrin-Durnerin I, Guivarc'h-Leveque A, Hugues JN; Groupe d'Etude en Medecine et Endocrinologie de la Reproduction. Pretreatment with estrogen does not affect IVF-ICSI cycle outcome compared with no pretreatment in GnRH antagonist protocol: a prospective randomized trial. Fertil Steril. 2012 Jun;97(6):1359-64.e1. doi: 10.1016/j.fertnstert.2012.02.028. Epub 2012 Mar 28.
citation: Sefrioui O, Madkour A, Kaarouch I, Louanjli N. Luteal estradiol pretreatment of poor and normal responders during GnRH antagonist protocol. Gynecol Endocrinol. 2019 Dec;35(12):1067-1071. doi: 10.1080/09513590.2019.1622086. Epub 2019 May 29.