Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201905470796922 Date of Approval: 15/05/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title AGES hysteroscopy-IVF trial
Official scientific title Effects of routine hysteroscopy on the reproductive outcomes in women undergoing IVF cycle: a randomised controlled trial
Brief summary describing the background and objectives of the trial Pregnancy rate following one cycle of in vitro fertilization (IVF) can be high but even in the very successful units; some couples may fail repeatedly. Such failure could be frustrating for both the patients and the IVF providers. A number of interventions have been proposed to improve IVF outcome, many of which may not be evidence-based and their efficacy is uncertain. One of the common interventions is screening hysteroscopy for evaluation of uterine cavity prior to IVF. Currently, there is no high-quality evidence to support the routine use of hysteroscopy as a screening tool for women undergoing IVF treatment. OBJECTIVES: To evaluate hysteroscopy in the routine assessment of uterine pathologies in infertile women undergoing IVF, and explore whether removal of such pathologies, if present, increases the rate of pregnancy and live births in such women undergoing IVF.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) AGES Hysteroscopy IVF trial
Disease(s) or condition(s) being studied Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied Fertility-female
Purpose of the trial Early detection /Screening
Anticipated trial start date 01/07/2019
Actual trial start date
Anticipated date of last follow up 31/12/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 770
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomization Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Hysteroscopy group Women will be scheduled for hysteroscopy in the early to midfollicular phase of the menstrual cycle, one to three months before the start of IVF treatment. once Women to be assigned to the intervention group will be scheduled for hysteroscopy in the early to midfollicular phase of the menstrual cycle in an outpatient setting without anaesthesia, one to three months before the start of IVF treatment. A paracervical block may be offered in cases of patient intolerance. 385
Control Group No hysteroscopy No hysteroscopy group will proceed to IVF for 1 to 3 attempts. Once Commencing IVF without prior hysteroscopy. 385 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All consenting infertile women, scheduled to start IVF or ICSI treatment. Women having a normal transvaginal ultrasound of the uterine cavity (defined as no visible intracavitary pathology—eg, submucous myomas, polyps, or septa). Women who will be planning cycles of preimplantation genetic testing. Women with a diagnosis of a congenital or acquired uterine abnormality (such as a uterine malformation, adenomyosis, submucous myoma, or intrauterine adhesion). Women with medical conditions that are contraindications to IVF procedures or pregnancy, such as uncontrolled hypertension, known symptomatic heart disease, poorly controlled type 1 or type 2 diabetes, undiagnosed liver disease or dysfunction, renal disease, severe anaemia, history of deep venous thrombosis, history of pulmonary embolus, previous cerebrovascular accident, or history of cervical cancer, endometrial cancer, or breast cancer. Women who will be planning to undergo frozen embryo transfer. Women with poor ovarian reserve using FSH of >9iu. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 65 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 13/06/2019 NAUTH Ethics Committee
Ethics Committee Address
Street address City Postal code Country
49 Nnewi Onitsha road Nnewi 435001 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome proportion with a clinically recognized pregnancy 12 weeks post transfer
Primary Outcome live birth rate At delivery
Secondary Outcome chemical pregnancy rate 4 weeks from last menstrual period
Secondary Outcome miscarriage rate after conception
Secondary Outcome ectopic pregnancy rate after conception
Secondary Outcome procedure (hysteroscopy) related complications at end of hysteroscopy
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Life specialist hospitals Awka 6 Awka Enugu Road Awka Nigeria
Gynescope Specialist Hospital 3 Off Airforce-Eliozu Expressway, Rukpakulusi New Layout Portharcourt Nigeria
South Shore Women and Children Hospital Plot 1717 Mike Adenuga Close, Off Adeola Odeku Street, VI, Lagos Lagos Nigeria
Ayomide Women Health Specialist Hospital and Womb seed Fertility Clinic 30, Second Gate, Power Station, Powerline, Ikirun Road,, Oshogbo, Osun Oshogbo Nigeria
Kingswill Specialist Hospital Amuwo Odofin, Festac Town Lagos Nigeria
Medison Specialist Women Hospital 18b Olatunji Moore St., Off F. T Kuboye St., Off Remi Oluwude Street, Lekki Phase 1, Lekki Lagos Nigeria
Federal Medical Centre Lokoja, Lokoja Nigeria
Life Specialist Hospital Nnewi No 7 Ikemba Drive, Umuele, Umudim 435101, Nnewi Nnewi Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Life specialist Hospital No 7 Ikemba Drive, Umuele, Umudim 435101, Nnewi Nnewi Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor LIFE SPECIALIST HOSPITAL No 7 Ikemba Drive, Umuele, Umudim 435101, Nnewi Nnewi Nigeria Hospital
Secondary Sponsor Gynescope specialist hospital G U Ake Road, 24 Gynescope Drive, Port Harcourt Portharcourt Nigeria Hospital
COLLABORATORS
Name Street address City Postal code Country
PROF JOSEPH IKECHEBELU No 7 Ikemba Drive, Umuele, Umudim 435101, Nnewi Nnewi Nigeria
DR. ALABI OLAJUWON Plot 1717, Mike Adenuga Close, Off Adeola Odeku Street, Victoria Lagos Nigeria
DR. ADEWOLE ADEBAYO Federal Medical Centre Lokoja Lokoja Nigeria
DR LATEEF AKINOLA 18b Olatunji Moore St., Off Remi Oluwude St., Lekki Phase 1,, Ibeju/Lekki Lagos Nigeria
DR Bolarinde Ola Sheffield, South Yorkshire United Kingdom United Kingdom
DR EMMANUEL KALU Kingston Hospital NHS Foundation Trust Kingston United Kingdom
DR. KINGSLEY ONWUZURIGBO KINGSWILL SPECIALIST HOSPITAL Lagos Nigeria
DR. KOMOLAFE JOHNSON 30, Second Gate, Power Station, Powerline, Ikirun Road,, Oshogbo, Osun Oshogbo Nigeria
DR. JUDE OKOHUE Off Airforce-Eliozu Expressway, Port Harcourt, Rivers, Nigeria. Portharcourt Nigeria
DR CHIGOZIE OKAFOR Nnamdi Azikiwe University Teaching Hospital Nnewi Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator GEORGE ELEJE georgel21@yahoo.com +2348068117444 Nnamdi Azikiwe University AWKA
City Postal code Country Position/Affiliation
Awka Nigeria Senior Lecturer and consultant
Role Name Email Phone Street address
Scientific Enquiries JOSEPH IKECHEBELU ji.ikechebelu@unizik.edu.ng +2348068117444 Life specialist Hospital
City Postal code Country Position/Affiliation
Nnewi Nigeria Professor
Role Name Email Phone Street address
Public Enquiries ALABI OLAJUWON christianalabi@gmail.com +2348056875395 South Shore Womens and Children Hospital
City Postal code Country Position/Affiliation
Lagos Nigeria CONSULTANT
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes PROFORMA APPENDIX 2: PROFORMA: Effects of routine hysteroscopy on the reproductive outcomes in women having their first or a subsequent IVF cycle: a multicentre, randomised controlled trial. NAME OF DOCTOR................................................CODE NUMBER OF PATIENT……………………… (1). Phone NUMBER OF PATIENT..........................(2) Center………………………… (3). DATE OF RECRUITMENT......................(4) TIME..................(5) AGE....................... (6.) Marital status: Married [ ] [single [ ] Divorced [ ](7.) LMP………..(8)Duration of infertility:.............. (9). Parity.................(10). Body weight-.............(11). Height: (cm)...................................................... TICK [X] OR WRITE WHICHEVER IS APPROPRIATE. (12) RETROVIRAL DISEASE STATUS a.) Negative [ ] (b) Positive [ ] (13.) Smoking history: Yes [ ] , No [ ] (14). HIGHEST EDU LEVEL.................................(15.) OCCUPATION (Specify).............................. (16). PREVIOUS IVF cycle? (a.) YES—-(b.) NO----- (16B) Known Hypertensive Yes [ ], NO [ ] (16B) Known Diabetic Yes [ ], No [ ] (17). Type of Infertility: Primary [ ] Secondary [ ] 18.) Cause of infertility: Male [ ], Tubal [ ], Anovulation [ ] Uterine [ ], Endometriosis [ ], Unexplained [ ] 18) Type of Oocyte transfer: Fresh [ ] Frozen [ ] 19.) Day of transfer: 2 [ ], 3 [ ], 5 [ ] 20. Number of cycles before Ongoing pregnancy resulting in livebirth: one [ ], Two [ ], Three [ ], Four [ ], five [ ], Greater than 5 [ ] (21). FINDINGS BEFORE AND AFTER Hysteroscopy.......? TICK [√] below: VARIABLE BEFORE Hysteroscopy PRESENCE ABSENCE VARIABLE AFTER hysteroscopy PRESENCE ABSENCE Polyps Polyps Fibroids Fibroids Uterine adhesion Uterine Adhesion Inflammation Inflammation Retained fetal bone Retained fetal bone Septa Septa 19. OUTCOME MEASURES [Tick or write whichever applies] LABORATORY VAR Informed Consent Form,Study Protocol AUGUST 2019 TO AUGUST 2021 OPEN
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
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