Clinical trial NCT05286554: Addition of Gonadotropin Releasing Hormone Agonist to Luteal Phase Support
Official title: Impact of Addition of Gonadotropin Releasing Hormone Agonist to Luteal Phase Support on Antagonist ICSI Cycles
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Female Infertility
Keywords: luteal phase support, ICSI, gonadotropin releasing hormone agonist
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2022-03-18
Enrollment: 75
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Hormonal milieu during implantation is crucial to embryo-endometrium interaction and to the viability of the conceptus. Alterations in the peri-implantation environment are considered to impair perinatal outcomes in intracytoplasmic sperm injection (ICSI) therapy. GnRH-a is a new and promising modality for LPS. Regimens for using GnRH-a in LPS, including single mid-luteal bolus or the addition of a GnRH-a to progesterone supplementation, have been recently suggested. The aim of this study is to evaluate the impact of addition of mid-luteal single-dose or multiple-dose GnRH agonist to the routine luteal phase support in patients undergoing ICSI cycles using GnRH antagonist protocol.


Eligibility criteria: Inclusion Criteria:

1. Patient age ≤ 38 years.
2. BMI ≤ 30.
3. Basal follicle stimulating hormone (FSH) level ≤ 10 IU/L.
4. Anti-Müllerian hormone (AMH): ≤ 5 ng/ml.

Exclusion Criteria:

1. Endometriosis.
2. Polycystic ovarian syndrome (PCOS).
3. Uterine pathology or anomaly.
4. Evidence of hydrosalpinx by hysterosalpingography or ultrasound.
5. Comorbidities: Diabetes mellitus, hypertension, immune diseases.

Primary outcomes:
measure: Clinical pregnancy rate
timeFrame: 2 weeks after positive pregnancy test
Secondary outcomes:
measure: Implantation rate
timeFrame: 2 weeks after positive pregnancy test
measure: Multiple pregnancy rate
timeFrame: 8 weeks of gestation
measure: Serum β-human chorionic gonadotropin (β-HCG) concentration
timeFrame: 15 days after ICSI
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria University
Study officials:
affiliation: Alexandria Univsersity
name: Mervat Sheikh El-arab, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Alexandria Univsersity
name: Ahmed Abdel Aziz, PhD
role: STUDY_DIRECTOR
References:
citation: de Ziegler D, Pirtea P, Andersen CY, Ayoubi JM. Role of gonadotropin-releasing hormone agonists, human chorionic gonadotropin (hCG), progesterone, and estrogen in luteal phase support after hCG triggering, and when in pregnancy hormonal support can be stopped. Fertil Steril. 2018 May;109(5):749-755. doi: 10.1016/j.fertnstert.2018.03.006.
citation: Thomsen LH, Kesmodel US, Andersen CY, Humaidan P. Daytime Variation in Serum Progesterone During the Mid-Luteal Phase in Women Undergoing In Vitro Fertilization Treatment. Front Endocrinol (Lausanne). 2018 Mar 19;9:92. doi: 10.3389/fendo.2018.00092. eCollection 2018.
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citation: Ma X, Du W, Hu J, Yang Y, Zhang X. Effect of Gonadotrophin-Releasing Hormone Agonist Addition for Luteal Support on Pregnancy Outcome in vitro Fertilization/Intracytoplasmic Sperm Injection Cycles: A Meta-Analysis Based on Randomized Controlled Trials. Gynecol Obstet Invest. 2020;85(1):13-25. doi: 10.1159/000501204. Epub 2019 Aug 16.
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citation: Qu D, Li Y. Multiple-dose versus single-dose gonadotropin-releasing hormone agonist after first in vitro fertilization failure associated with luteal phase deficiency: A randomized controlled trial. J Int Med Res. 2020 Jun;48(6):300060520926026. doi: 10.1177/0300060520926026.