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

NCT ID: NCT04539613

Last Updated: 2020-09-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-09-01

Study Completion Date

2021-02-01

Brief Summary

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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

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, 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).

Conditions

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Ovarian Stimulation in ICSI

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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group1

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

HPFSH & HMG

Intervention Type DRUG

. Various gonadotropin preparations

group2

Group 2(50 case) will be treated with recombinant FSH alone (Gonal-F) (150 IU per ampoule)

No interventions assigned to this group

Interventions

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HPFSH & HMG

. Various gonadotropin preparations

Intervention Type DRUG

Other Intervention Names

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rec-F.S.H

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Alaa Fouli Gaber Ebrahim

OTHER

Sponsor Role lead

Responsible Party

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Alaa Fouli Gaber Ebrahim

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

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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El neel

Minya, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Amna Abdel sabour

Role: CONTACT

01092405752

kareem shaheen

Role: CONTACT

01003957442

Facility Contacts

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Kareem shaheen

Role: primary

+201003957442

References

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Kamel RM. The onset of human parturition. Arch Gynecol Obstet. 2010 Jun;281(6):975-82. doi: 10.1007/s00404-010-1365-9. Epub 2010 Feb 3.

Reference Type BACKGROUND
PMID: 20127346 (View on PubMed)

Other Identifiers

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COH in ICSI

Identifier Type: -

Identifier Source: org_study_id

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