Long Protocol and Growth Hormone in Poor Responders

NCT ID: NCT02338206

Last Updated: 2017-11-29

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

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2017-11-15

Brief Summary

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The long down regulation protocol is widely used in the in vitro fertilization cycles, now it will be assessed regarding its efficacy, in poor responder females undergoing in vitro fertilization cycles, alone and after the addition of growth hormone.

Detailed Description

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Conditions

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Infertility

Keywords

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infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Long + Growth hormone

Patients in this group were given a long protocol of pituitary down-regulation with triptorelin (Decapeptyl; Ferring, Switzerland) starting on the day 21 of preceding cycle at a dose of 0.1 mg/day, subcutaneously along with Growth hormone (Norditropin, Novo nordisk) co-treatment daily in a dose of 2.5 mg S.C. till the day of hCG administration.. On the second day of menstruation, Human menopausal gonadotrophin HMG (75 IU, Merional, IBSA) was started, and this was associated with reduction of triptorelin dose to 0.05 mg/day. This reduced daily dose, in addition to HMG and growth hormone, were continued till the day of hCG administration.

Group Type ACTIVE_COMPARATOR

Growth hormone

Intervention Type DRUG

Long protocol only

Patients in this group were given a long protocol of pituitary down-regulation with triptorelin (Decapeptyl; Ferring, Switzerland) starting on the day 21 of preceding cycle at a dose of 0.1 mg/day, subcutaneously. On the second day of menstruation, Human menopausal gonadotrophin HMG (75 IU, Merional, IBSA) was started, and this was associated with reduction of triptorelin dose to 0.05 mg/day. This reduced daily dose, in addition to HMG, were continued till the day of hCG administration.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Growth hormone

Intervention Type DRUG

Other Intervention Names

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Norditropin, Novo nordisk

Eligibility Criteria

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Inclusion Criteria

* Poor responder females are those who posses two out of these three criteria:
* Female age ≥40 years
* Females who have at least one previous cancelled IVF cycle
* POR according to AFC ≤ 5 or low AMH value.

Exclusion Criteria

* Females over 45 years
* Females with FSH more than 20 IU/l
* Females with previous ovarian surgery
* Females suffering from causes of infertility other than poor ovarian response
* Females refusing to be enrolled in the study
Minimum Eligible Age

20 Years

Maximum Eligible Age

44 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role collaborator

Woman's Health University Hospital, Egypt

OTHER

Sponsor Role lead

Responsible Party

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Dina Mohamed Refaat Dakhly

lecturer of obstetrics and gynecology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dina M Dakhly, MD

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

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Kasr el aini hospital

Cairo, , Egypt

Site Status

Countries

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Egypt

References

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Dakhly DMR, Bassiouny YA, Bayoumi YA, Hassan MA, Gouda HM, Hassan AA. The addition of growth hormone adjuvant therapy to the long down regulation protocol in poor responders undergoing in vitro fertilization: Randomized control trial. Eur J Obstet Gynecol Reprod Biol. 2018 Sep;228:161-165. doi: 10.1016/j.ejogrb.2018.06.035. Epub 2018 Jun 22.

Reference Type DERIVED
PMID: 29957401 (View on PubMed)

Other Identifiers

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LP112015

Identifier Type: -

Identifier Source: org_study_id