Controlled Ovarian Hyperstimulation (COH) With Sequential HPFSH & HMG Versus Rec-F.S.H Alone in ICSI Cycle

• Conditions: Ovarian Stimulation in ICSI
• Interventions: Drug: HPFSH & HMG

• Registration Number: NCT04539613
• Lead Sponsor: Alaa Fouli Gaber Ebrahim

Brief Summary

despite the large number of papers published on COH protocols comparing the efficiency of different exogenous gonadotropins, no confirmed protocol exists, and it is not quite clear which is superior to the others.

Detailed Description

, the objective of the current study was to compare the efficacy of 2 different ovarian stimulation protocols, comprising hpFSH, HMG versus R-FSH on oocyte and embryo quality and IVF treatment outcome in patients undergoing IVF or intracytoplasmic sperm injection (ICSI)(4).

Study Timeline

• Status Verified: 2020-08
• Study First Submitted: 2020-08-31
• Study First Submitted QC: 2020-08-31
• Last Update Submitted: 2020-08-31
• Study Start: 2020-09-01
• Study First Posted: 2020-09-07
• Last Update Posted: 2020-09-07
• Primary Completion: 2021-01-01
• Study Completion: 2021-02-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• 1-Aged 20-35 yr, male factor, 2-Tubal or unexplained infertility, 3-regular menstruation cycle between 21 and 35 days, 4-Normal function of uterus according to hysterosalpingography, hysteroscopy or transvaginal ultrasonography, 5-Normal ovaries according to transvaginal ultrasonography during past 6 months prior to study and compatible with normal adnexa and 6-Normal ovarian anatomy, and serum FSH level less than 8 IU/l All women showed no recognizable endometriosis according to symptoms and clinical examination in transvaginal ultrasonography or diagnostic laparoscopy. 7-7-All women have a history of unexplained infertility 8-Normal ovulatory function and normal semen analysis according to the World Health Organization criteria .

Exclusion Criteria

• Patients with other ovulation disorders such as hypo and hypergonadotropic, hypogonadism, hyperprolactinemia.

  2-Thyroid disorders. 3-Ovarian or adrenal neoplasms. 4-Cushing syndrome. 5-previous history of systemic diseases such as endocrine and metabolic disorders.

  6- Previous history of inappropriate ovarian response to stimulation with gonadotropins (poor responders).

  7-Prior history of more than 3 unsucce

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
group1	HPFSH & HMG	Group 1(50 case) which will receive hp FSH (fostimon ibsa) (150 IU per ampoule)will be started on day 2 of menstruation and then after six days, HMG (meriofert ibsa), 150 Iu, s.c) will be added

Primary Outcome Measures

Name	Time	Method
fertility outcomes (pregnancy rate, abortion and live birth rate) in IVF patients.	5months	(pregnancy rate, abortion and live birth rate) in IVF patients.

Trial Locations

Locations (1)

El neel; 🇪🇬 Minya, Egypt