Prediction of Metaphase II Oocytes According to Different Levels of Serum AMH in Poor Responders Using the Antagonist Protocol

NCT03484611 | Unknown DMC

• 1 other identifier: 35
• Study Type: interventional
• Target: 179
• Locations: 1 country
• Sites: 1

Brief Summary

A multicentric study looked into 179 poor responders who underwent antagonist protocol in ICSI cycles Gonadotrophines is started on day 2 with HMG until the day of HCG administration with starting dose 300IU to 450IU,with no pretreatment with OCPs or progestogens or estrogen. GNRH antagonist (cetrorelix 0,25mg s.c, cetrotide, serono laboratories, Aubonne Switzerland) is given using flexible protocol, it is given when at least one follicle reaches size 14 mm to prevent premature lutenization ,until the day of hCG administration Ovarian ultrasound scans were performed using a 5.0-9.0 MHZ multi frequency trans vaginal probe to assess the ovarian response till the mature follicles reach18-20mm when hCG administration 10000 IU is given to induce final oocytes maturation , serum E2 is done on day of HCG trigger. Trans vaginal ultrasound-guided oocyte retrieval is performed 34-36 hours after hCG injection. Ultrasound -guided fresh embryo transfer is performed on day 3 or 5 after fertilization. Progesterone support of luteal phase was commenced on the day of ovum pick up using prontogest 400 mg twice daily.

Conditions

Invitro Fertilizaion

Outcome Measures

Primary Outcomes (1)

• Number of the retrieved oocytes

  number of oocytes retrieved 34 hours after HCG injection

  34 hours after HCG injection

Study Arms (3)

AMH < 0.3 ng/ml

ACTIVE COMPARATOR

Poor ovarian responders according to ESHRE consensus with serum AMH \< 0,3 ng/ml

Drug: GnRH antagonist; Drug: Gonadotropins; Drug: Human chorionic gonadotropin; Procedure: Embryo transfer; Drug: Progesterone

AMH 0.3 to 0.7 ng/ml

ACTIVE COMPARATOR

Poor ovarian responders according to ESHRE consensus with serum AMH 0.3 to 0.7 ng/ml

Drug: GnRH antagonist; Drug: Gonadotropins; Drug: Human chorionic gonadotropin; Procedure: Embryo transfer; Drug: Progesterone

AMH > 0.7 to 1 ng/ml

ACTIVE COMPARATOR

Poor ovarian responders according to ESHRE consensus with serum AMH 0.7 to 1 ng/ml

Drug: GnRH antagonist; Drug: Gonadotropins; Drug: Human chorionic gonadotropin; Procedure: Embryo transfer; Drug: Progesterone

Interventions

GnRH antagonist DRUG

0,25mg s.c, cetrotide, serono laboratories, Aubonne Switzerland) is given using flexible protocol, it is given when at least one follicle reaches size 14 mm to prevent premature lutenization ,until the day of hCG administration

Also known as: cetrorelix

AMH 0.3 to 0.7 ng/ml; AMH < 0.3 ng/ml; AMH > 0.7 to 1 ng/ml

Gonadotropins DRUG

started on day 2 of the menstrual cycle until the day of HCG administration(choriomon,IBSA10000IU)with starting dose 300IU to 450IU

Also known as: Human menopausal gonadotropin

AMH 0.3 to 0.7 ng/ml; AMH < 0.3 ng/ml; AMH > 0.7 to 1 ng/ml

Human chorionic gonadotropin DRUG

10000 IU is given to induce final oocytes maturation when at least 2 follicles reached 14 mm or more

Also known as: HCG

AMH 0.3 to 0.7 ng/ml; AMH < 0.3 ng/ml; AMH > 0.7 to 1 ng/ml

Embryo transfer PROCEDURE

0ne to three grade 1 or 2 embryos were transferred on day 3 after oocyte retrieval. Embryo transfer was performed with a Wallace catheter (Smith Medical International Ltd, Hythe, Kent, UK)

AMH 0.3 to 0.7 ng/ml; AMH < 0.3 ng/ml; AMH > 0.7 to 1 ng/ml

Progesterone DRUG

vaginal prontogest 400 mg twice daily

AMH 0.3 to 0.7 ng/ml; AMH < 0.3 ng/ml; AMH > 0.7 to 1 ng/ml

Eligibility Criteria

• Age: 20 Years - 45 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• On antagonist protocol 4- Poor responder according to ESHRE consensus; in which at least 2 of the following should be present:
• Advanced maternal age (≥ 40 years old) or any other risk factor
• A previous poor ovarian response (cycles cancelled or ≤ 3 oocytes with a conventional protocol)
• An abnormal ovarian reserve test (ORT); antral follicle count (AFC) \< 5-7 follicles or anti-mullerian hormone (AMH) ≤0.5- 1.1 ng/ml NB: In the absence of advanced maternal age or abnormal ORT, two previous episodes of poor ovarian response after maximal stimulation patients are also considered poor responders according to ESHRE consensus.
• Presence and Adequate visualization of both ovaries
• Uterine cavity within normal anatomy

You may not qualify if:

• Any factor which may affect reproductive outcome other than that the patient is a poor responder will be excluded from the study, like:
• Severe male factor .
• Uterine factor (eg: fibroid, polyp, Ashermann, .. etc)
• Immunological disorder (eg: SLE, APS, … etc)
• Thyroid or adrenal dysfunction
• Neoplasia (especially: hypothalamic, pit, ovarian)
• Women diagnosed with PCOS according to Rotterdam criteria
• Hydrosalpinx that hasn't been surgically removed or ligated. 8 . Untreated hyperprolactinemia 9 . Abnormal bleeding disorder
• Hepatic or renal dysfunction 11.Hypersenstivity to study medication ( GNRH antagonist) 12.Need to take medication that can influence ovarian stimulation 13.Endometriosis grade 3 or 4 14.Ovarian cyst\> 10 cm.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Kasr Alainy medical school

Cairo, 12111, Egypt

RECRUITING

MeSH Terms

Interventions

LHRH, Ac-Nal(1)-Cpa(2)-Trp(3)-Arg(6)-Ala(10)-; cetrorelix; Gonadotropins; Menotropins; Chorionic Gonadotropin; Embryo Transfer; Progesterone

Intervention Hierarchy (Ancestors)

Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Gonadotropins, Pituitary; Pituitary Hormones, Anterior; Pituitary Hormones; Peptides; Amino Acids, Peptides, and Proteins; Biological Products; Complex Mixtures; Placental Hormones; Pregnancy Proteins; Proteins; Reproductive Techniques, Assisted; Reproductive Techniques; Therapeutics; Investigative Techniques; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Corpus Luteum Hormones; Gonadal Hormones; Progesterone Congeners; Gonadal Steroid Hormones

Study Officials

• Ahmed Maged, MD

  professor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed Maged, MD

CONTACT

+2001005227404; prof.ahmedmaged@gmail.com

Radwa Fahmy, MD

CONTACT

radwafahmi@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: March 26, 2018
• First Posted: April 2, 2018
• Study Start: January 1, 2013
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: April 2, 2018

Record last verified: 2018-03

Locations

EG (1)