Growth Hormone Pretreatment in Poseidon Type IV Undergoing ICSI Using Minimal Induction Protocol: A Randomized Controlled Trial

NCT05089344 | Unknown DMC

• 1 other identifier: GH in poor responders
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

Brief Summary

This study is done aiming to Assess Efficiency of Growth hormone as an adjuvant in pretreatment of Poseidon type IV group " poor responders "undergoing ICSI using minimal induction protocol

Conditions

Poor Response to Ovulation Induction Poseidon Type IV

Outcome Measures

Primary Outcomes (1)

• Ongoing pregnancy rate

  pregnancy continuing after 20th week of gestation.

  20 week of gestation

Secondary Outcomes (1)

• - Biochemical pregnancy rate

  2 weeks after embryo transfer

Study Arms (2)

mild stimulation protocol + growth hormone adjuvant

EXPERIMENTAL

Controlled ovarian hyperstimulation protocol will be held according to a flexible GnRH antagonist protocol + Clomophine citrate. Ovarian stimulation will start with a fixed daily dose of 100 mg of Clomiphene citrate daily and recombinant FSH (Gonal-F®) will be started on day 2 of the menstrual cycle at a dose of 150 IU to be adjusted thereafter in a step up fashion every 2 to 4 days according to ovarian response . . For those in the GH group, 8 IU recombinant human GH will be administered starting from Day 14 of the previous cycle Till administration of HCG for ovulation triggering

Drug: Growth Hormone; Drug: Clomiphene citrate daily and recombinant FSH (Gonal-F®)

Mild stimuation protocol

ACTIVE COMPARATOR

Controlled ovarian hyperstimulation protocol will be held according to a flexible GnRH antagonist protocol + Clomophine citrate. Ovarian stimulation will start with a fixed daily dose of 100 mg of Clomiphene citrate daily and recombinant FSH (Gonal-F®) will be started on day 2 of the menstrual cycle at a dose of 150 IU to be adjusted thereafter in a step up fashion every 2 to 4 days according to ovarian response . .

Drug: Clomiphene citrate daily and recombinant FSH (Gonal-F®)

Interventions

Growth Hormone DRUG

growth hormone

mild stimulation protocol + growth hormone adjuvant

Clomiphene citrate daily and recombinant FSH (Gonal-F®) DRUG

Clomiphene citrate daily and recombinant FSH (Gonal-F®)

Mild stimuation protocol; mild stimulation protocol + growth hormone adjuvant

Eligibility Criteria

• Age: 35 Years - 42 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age group between 35 to 42 years old
• AFC \<5
• AMH \<1.2 ng/ml
• first IVF trial

You may not qualify if:

• \- Serious and unstable disease, such as cerebrovascular, liver, and kidney disease "will be unfit for pregnancy".
• History of malignant or border line tumors "will be unfit for pregnancy".
• Endocrine or metabolic disorder "affecting quality of oocyte so affecting results".
• Either one of the couple with chromosomal abnormalities "affecting quality of oocyte so affecting results".
• Male partner with severe oligoasthenozoospermia or with teratozoospermia"affecting quality of embryo to be transfered so affecting results".
• Any contraindications to growth hormone, pregnancy (to be ruled out and documented before GH treatment).
• female patients with causes of infertility other than poor ovarian reserve
• females suffering from congenital or acquired uterine anomalies "will affect results of implantation and pregnancy rates "
• females with focal uterine lesions anomalies "will affect results of implantation and pregnancy rates "
• BMI \>30 kg/m2 "affecting quality of oocyte so affecting results".

Sponsors & Collaborators

• Ain Shams Maternity Hospital: lead

Study Sites (1)

AinShams University

Cairo, 11856, Egypt

RECRUITING

MeSH Terms

Interventions

Growth Hormone; follitropin alfa

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Anterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Moustafa Fouad, MD

  Ainshams Maternity Hospital

  PRINCIPAL INVESTIGATOR

• Ebtihal ElTaieb, MD

  Ainshams Maternity Hospital

  STUDY DIRECTOR

Central Study Contacts

Ahmed ElSaed, Master

CONTACT

01003704003; AhmedMohamedElSaed13@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: October 9, 2021
• First Posted: October 22, 2021
• Study Start: October 9, 2021
• Primary Completion: October 30, 2022
• Study Completion: December 30, 2022
• Last Updated: October 22, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)