Value of Cabergoline and Low Dose Aspirin in Poor Responders Undergoing ICSI-ET With GnRH Agonist Flare-Up-Protocol

NCT03263299 | Unknown Phase 4 DMC

• 1 other identifier: 8
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Ovarian stimulation will be done using the Microdose flare-up regimen. The patient will receive diluted doses of the GnRH agonist leuprolide acetate 40 µg, given subcutaneously twice daily. Two days later, stimulation will be initiated by intramuscular (IM) injections of HMG (Merional, IBSA, Germany) in a dose of 300 IU/day. Follicular monitoring began from the ninth day of the cycle by serial vaginal ultrasonography and measurement of serum E2 levels. IM injections of 10000 IU HCG (Choriomon; IBSA, Germany) will be injected when at least 2 follicles 18 mm were observed on ultrasonography. Oocytes willbe retrieved 36 hours after hCG injection using a 17-gauge aspiration needle under transvaginal ultrasound guidance. The pelvis is evaluated with ultrasound to ensure that there is no internal bleeding. After fertilization was confirmed when two polar bodies and two pronuclear were observed 18-20 hours after insemination, one to three grade A embryos were transferred at day 3 fertilization. The luteal phase support will be initiated from the day of oocyte retrieval for all patients with (Cyclogest 400 mg, Actavis pharmaceutical, UK) vaginal suppositories per day till the day of serum pregnancy test was done.

Conditions

Invitro Fertilization

Outcome Measures

Primary Outcomes (1)

• clinical pregnancy

  Intrauterine gestational sac detection by transvaginal ultrasound

  4 weeks after embryo transfer

Study Arms (3)

cabergoline group

ACTIVE COMPARATOR

received cabergoline in addition to aspirin. Cabergoline was administered in a dose of 1 mg/week in two divided doses which was terminated after embryo transfer. Aspirin was administered in daily dose of 80 mg initiated at the start of down-regulation with luteal leuprolide

Drug: cabergoline; Drug: Aspirin; Drug: GnRH agonist

Aspirin group

ACTIVE COMPARATOR

Aspirin was administered in daily dose of 80 mg initiated at the start of down-regulation with luteal leuprolide

Drug: Aspirin; Drug: GnRH agonist

GnRH Group

ACTIVE COMPARATOR

Microdose flare-up regimen. The patient received diluted doses of the GnRH agonist leuprolide acetate 40 µg, given subcutaneously twice daily. Two days later, stimulation is initiated by intramuscular (IM) injections of HMG (Merional, IBSA, Germany) in a dose of 300 IU/day.

Drug: GnRH agonist

Interventions

cabergoline DRUG

Cabergoline was administered in a dose of 1 mg/week in two divided doses which was terminated after embryo transfer

cabergoline group

Aspirin DRUG

Aspirin was administered in daily dose of 80 mg initiated at the start of down-regulation with luteal leuprolide

Aspirin group; cabergoline group

GnRH agonist DRUG

Microdose flare-up regimen. The patient received diluted doses of the GnRH agonist leuprolide acetate 40 µg, given subcutaneously twice daily. Two days later, stimulation is initiated by intramuscular (IM) injections of HMG (Merional, IBSA, Germany) in a dose of 300 IU/day.

Aspirin group; GnRH Group; cabergoline group

Eligibility Criteria

• Age: 20 Years - 39 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with a history of one or more failed IVF cycles with three or less retrieved oocytes
• No age limitation
• Patients with an inadequate ovarian response in previous cycle
• Low estradiol (E2) levels in response to ovarian stimulation in previous cycle
• Lower number of retrieved oocytes in previous trials.

You may not qualify if:

• Severe male factor (azospermia)
• Hydrosalpinx
• History of endometriosis
• Endocrine or metabolic disorders
• Follicle stimulating hormone (FSH) level \> 15 mIU.
• Antimullerian hormone (AMH)\< 0.5 ng/ml
• Any uterine causes of infertility e.g. septate uterus

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Kasr Alainy medical school

Cairo, 12151, Egypt

Location

MeSH Terms

Interventions

Cabergoline; Aspirin; Gonadotropin-Releasing Hormone

Intervention Hierarchy (Ancestors)

Ergolines; Ergot Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• Ahmed Maged, MD

  kasr Alainy medical school

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed Maged, MD

CONTACT

01005227404; prof.ahmedmaged@gmail.com

Ayman Hany, MD

CONTACT

aymanobgyn@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 24, 2017
• First Posted: August 28, 2017
• Study Start: August 1, 2017
• Primary Completion: August 1, 2018
• Study Completion: September 1, 2018
• Last Updated: August 28, 2017

Record last verified: 2017-08

Locations

EG (1)