Comparative Study Between Single Versus Dual Trigger for Poor Responders in GnRH-antagonist ICSI Cycles

NCT04008966 | Completed Phase 4 DMC

• 1 other identifier: 58
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

All participants started with a combination of recombinant FSH 300 U and urinary Gn 150 U from the 2nd day of the cycle then the dose was adjusted according to the ovarian response From day 6 of the cycle, follow up using transvaginal ultrasound was done either daily or on alternate days according to the ovarian response. When the leading follicle reached 12 mm, GnRH antagonist was started using Cetrotide 0.25 subcutaneously daily till the day of triggering. Triggering was done when at least 3 follicles larger than 14 mm and at least one of them reached a mean diameter of 17 mm or more. At the day of triggering, women were randomized into 2 groups. Group I (single trigger group) that included 80 women who received triggering in the form of 10,000 IU of HCG intramuscular injection. Group II (Dual trigger group) that included 80 women who received triggering in the form of 10,000 IU of HCG intramuscular injection in addition to GnRH agonist triptorelin 0.2 mg subcutaneously. Ovum pickup was done 34 hours after triggering under the guidance of transvaginal ultrasound. ISM1 culture medium was used for oocyte collection and embryo culture. Transabdominal ultrasound guided embryo transfer was done 3 days after oocyte retrieval using Labotect semirigid catheter by the same expert operator Cycle cancellation was done if day 9 folliculometry revealed less than 2 mature follicles, no oocytes were retrieved or if fertilization failed Luteal phase support was started in all women on the day of oocyte retrieval and continued till the day of serum β-hCG assessment (done 14 days after ET) through administration of 400 mg of natural Progesterone twice daily per vagina . In women with +ve serum β-hCG (\> 5 mIU/ml), transvaginal ultrasound evaluation was done 4 weeks after ET to confirm the presence and number of intrauterine gestational sacs.

Conditions

Assisted Reproduction

Outcome Measures

Primary Outcomes (1)

• number of mature follicular count

  number of follicles larger than 14 mm

  10 - 14 days of the cycle

Study Arms (2)

single trigger

ACTIVE COMPARATOR

80 women who received triggering in the form of 10,000 IU of HCG intramuscular injection

Drug: combined oral contaraceptive pills; Drug: recombinant FSH; Drug: Urinaru gonadotropin; Drug: GnRH antagonist; Drug: Human chorionic gonadotropin; Procedure: Ovum pick up; Procedure: Embryo transfer; Drug: natural Progesterone

Dual trigger

ACTIVE COMPARATOR

80 women who received triggering in the form of 10,000 IU of HCG intramuscular injection in addition to GnRH agonist triptorelin 0.2 mg subcutaneously

Drug: combined oral contaraceptive pills; Drug: recombinant FSH; Drug: Urinaru gonadotropin; Drug: GnRH antagonist; Drug: Human chorionic gonadotropin; Drug: GnRH agonist; Procedure: Ovum pick up; Procedure: Embryo transfer; Drug: natural Progesterone

Interventions

combined oral contaraceptive pills DRUG

1 tablet daily between days 5 and 25 of the cycle before stimulation

Also known as: Gynera

Dual trigger; single trigger

recombinant FSH DRUG

300 U from the 2nd day of the cycle then the dose was adjusted according to the ovarian response evaluated by transvaginal ultrasound and serum E2

Dual trigger; single trigger

Urinaru gonadotropin DRUG

150 U from the 2nd day of the cycle then the dose was adjusted according to the ovarian response evaluated by transvaginal ultrasound and serum E2

Dual trigger; single trigger

GnRH antagonist DRUG

0.25 subcutaneously daily from the day in which the leading follicles reached 12 mm till the day of triggering

Also known as: Cetrotide

Dual trigger; single trigger

Human chorionic gonadotropin DRUG

10,000 IU intramuscular when at least 3 follicles larger than 14 mm and at least one of them reached a mean diameter of 17 mm or more

Dual trigger; single trigger

GnRH agonist DRUG

0.2 mg subcutaneously when at least 3 follicles larger than 14 mm and at least one of them reached a mean diameter of 17 mm or more

Also known as: triptorelin

Dual trigger

Ovum pick up PROCEDURE

34 hours after triggering under the guidance of transvaginal ultrasound

Dual trigger; single trigger

Embryo transfer PROCEDURE

Transabdominal ultrasound guided embryo transfer was done 3 days after oocyte retrieval using Labotect semirigid catheter

Dual trigger; single trigger

natural Progesterone DRUG

400 mg twice daily per vagina

Also known as: Prontogest

Dual trigger; single trigger

Eligibility Criteria

• Age: 25 Years - 42 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• women with poor ovarian response candidate for ICSI
• women with spontaneous normal menstrual cycle
• normal uterine cavity

You may not qualify if:

• women with ovarian cysts
• endometriosis
• hydrosalpinx
• endocrinological disorders as hyperprolactinemia, thyroid or adrenal disorders.
• Couples with azospermic male partner
• those with severe uncontrolled medical or metabolic disorders

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Kasr Alainy medical school

Cairo, 12151, Egypt

Location

Related Publications (1)

• Maged AM, Ragab MA, Shohayeb A, Saber W, Ekladious S, Hussein EA, El-Mazny A, Hany A. Comparative study between single versus dual trigger for poor responders in GnRH-antagonist ICSI cycles: A randomized controlled study. Int J Gynaecol Obstet. 2021 Mar;152(3):395-400. doi: 10.1002/ijgo.13405. Epub 2020 Oct 22.

  PMID: 33011968 DERIVED

MeSH Terms

Interventions

LHRH, Ac-Nal(1)-Cpa(2)-Trp(3)-Arg(6)-Ala(10)-; cetrorelix; Chorionic Gonadotropin; Gonadotropin-Releasing Hormone; Triptorelin Pamoate; Embryo Transfer

Intervention Hierarchy (Ancestors)

Gonadotropins; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Placental Hormones; Peptides; Amino Acids, Peptides, and Proteins; Pregnancy Proteins; Proteins; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Neuropeptides; Oligopeptides; Nerve Tissue Proteins; Reproductive Techniques, Assisted; Reproductive Techniques; Therapeutics; Investigative Techniques

Study Officials

• Ahmed maged, MD

  Professor

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 2, 2019
• First Posted: July 5, 2019
• Study Start: July 20, 2016
• Primary Completion: June 2, 2019
• Study Completion: July 1, 2019
• Last Updated: July 5, 2019

Record last verified: 2019-07

Locations

EG (1)