Outcome of Cetrotide Therapy for Management of Women at High-risk of Ovarian Hyperstimulation Syndrome

NCT02823080 | Unknown Phase 2 Results DMC

• 2 other identifiers: Benha Ukmsalama
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate safety and efficacy of 3-day cetrotide therapy started on day of oocyte retrieval (Day-0) in women at high-risk for development of ovarian hyperstimulation syndrome (OHSS) after gonadotropin- releasing hormon agonist induction protocol. Patients \& Methods: Forty-eight women fulfilling inclusion criteria underwent ultrasound scanning for maximal ovarian diameter (MOD) estimation and ascites grading. Patients underwent embryo freezing, but study group received 3-day Cetrotide sc injection (0.25 mg/day) started on Day-0. Serum E2, pain scores and MOD were checked daily. Hematocrit value (Ht%), total leucocytic count (TLC), gastrointestinal (GI) manifestations and ascites grading were re-evaluated on Day-3, 6 and 8

Conditions

Infertility

Outcome Measures

Primary Outcomes (2)

• Daily Serum E2 Levels

  Serum E2 levels (Serum E2 level in picograms/ml) were evaluated daily.

  8 days

• Daily Maximal Ovarian Diameter

  MOD (maximal ovarian diameter in mm) were evaluated daily.

  8 days

Secondary Outcomes (4)

• Daily Numerical Pain Visual Analogue Scale Score

  8 days.

• Daily Hematocrits Value

  0-8 days.

• Ultrasound Detected Severity Grades of Ascites From Days 0-8

  0-8 days

• Daily Total Leucocytic Count

  0 -8days.

Other Outcomes (1)

• Resolution of Gastrointestinal Manifestations Determined Prior to Start of Therapy

  0-6 days

Study Arms (2)

cetrotide

ACTIVE COMPARATOR

study group (24 patients = intervention) received intervention for 3-daysCetrorelix Acetate sc injection (0.25 mg/day) started on Day-0. Serum E2, pain scores and MOD were checked daily. Hematocrit value (Ht%), total leucocytic count (TLC), gastrointestinal (GI) manifestations and ascites grading were re-evaluated on Day-3, 6 and 8.

Drug: Cetrorelix

no cetrotide

NO INTERVENTION

control group (24 patients) did not receive 3-daysCetrorelix Acetate (no intervention). Serum E2, pain scores and MOD were checked daily. Hematocrit value (Ht%), total leucocytic count (TLC), gastrointestinal (GI) manifestations and ascites grading were re-evaluated on Day-3, 6 and 8.

Interventions

Cetrorelix DRUG

study group received 3-day Cetrorelix Acetate sc injection (0.25 mg/day) started on Day-0. Serum E2, pain scores and MOD were checked daily. Hematocrit value (Ht%), total leucocytic count (TLC), gastrointestinal (GI) manifestations and ascites control (24 patients) did not receive Cetrorelix Acetate. Grading were re-evaluated on Day-3, 6 and 8.

Also known as: cetrotide

cetrotide

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• number of retrieved oocytes was ≥20
• mean number of follicles with a diameter of \>16 mm was ≥18
• serum E2 concentrations of ≥3500 pg/ml
• ovarian diameter on the day of ovum retrieval of \>10 cm
• presentation of evident symptoms of OHSS on the day of aspiration .

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Benha university hospitalا

Banhā, El Qalubia, Egypt

Location

Related Publications (5)

• Scott J, Huskisson EC. Graphic representation of pain. Pain. 1976 Jun;2(2):175-84. No abstract available.

  PMID: 1026900 BACKGROUND

• Lainas TG, Sfontouris IA, Zorzovilis IZ, Petsas GK, Lainas GT, Kolibianakis EM. Management of severe early ovarian hyperstimulation syndrome by re-initiation of GnRH antagonist. Reprod Biomed Online. 2007 Oct;15(4):408-12. doi: 10.1016/s1472-6483(10)60366-5.

  PMID: 17908403 BACKGROUND

• Albano C, Smitz J, Camus M, Riethmuller-Winzen H, Van Steirteghem A, Devroey P. Comparison of different doses of gonadotropin-releasing hormone antagonist Cetrorelix during controlled ovarian hyperstimulation. Fertil Steril. 1997 May;67(5):917-22. doi: 10.1016/s0015-0282(97)81407-0.

  PMID: 9130900 BACKGROUND

• Navot D, Bergh PA, Laufer N. Ovarian hyperstimulation syndrome in novel reproductive technologies: prevention and treatment. Fertil Steril. 1992 Aug;58(2):249-61. doi: 10.1016/s0015-0282(16)55188-7.

  PMID: 1633889 BACKGROUND

• Salama KM, Abo Ragab HM, El Sherbiny MF, Morsi AA, Souidan II. Sequential E2 levels not ovarian maximal diameter estimates were correlated with outcome of cetrotide therapy for management of women at high-risk of ovarian hyperstimulation syndrome: a randomized controlled study. BMC Womens Health. 2017 Nov 13;17(1):108. doi: 10.1186/s12905-017-0466-z.

  PMID: 29132339 DERIVED

Related Links

• infertility

MeSH Terms

Conditions

Infertility

Interventions

cetrorelix

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Limitations and Caveats

no Limitations and Caveats

Results Point of Contact

• Title: dr khalid M Salama
• Organization: Benha university

dr.khalid_sleem@yahoo.com

01225861026

Study Officials

• khalid M salama, MD

  Benha University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: director clinical research

Study Record Dates

• First Submitted: June 21, 2016
• First Posted: July 6, 2016
• Study Start: October 1, 2014
• Primary Completion: April 1, 2017
• Study Completion: May 1, 2017
• Last Updated: March 30, 2017
• Results First Posted: January 31, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)