Evidence map›Paper›PMID 31340957›Full record

ArticleBMJ open2019

The AID study: protocol for a randomised controlled trial of intrauterine insemination in the natural cycle compared with intracervical insemination in the natural cycle.

Petronella Kop, Madelon van Wely, Annemiek Nap, Ben Willem Mol, Rob Bernardus, Michael De Brucker, Pim Janssens, Ben Cohlen, Jacqueline Pieters, Sjoerd Repping and 2 more

Abstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Trial
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

Petronella KopCenter for Reproductive Medicine, Amsterdam Reproduction & Development Institute, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands p.a.kop@amc.uva.nl.
Madelon van WelyCenter for Reproductive Medicine, Amsterdam Reproduction & Development Institute, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands.
Annemiek NapDepartment of Gynaecology and Obstetrics, Rijnstate, Arnhem, Gelderland, Netherlands.
Ben Willem MolDepartment of Obstetrics and gynaecology, Monash University Central Clinical School, Melbourne, Victoria, Australia.
Rob BernardusFertility clinic, Nij Barrahus, Wolvega, Netherlands.
Michael De BruckerCentre for Reproductive Medicine, Universitair Ziekenhuis Brussel, Brussel, Belgium.
Pim JanssensClinical Chemistry and Haematology, Hospital Rijnstate, Arnhem, Gelderland, Netherlands.
Ben CohlenObstetrics and Gynaecology, Isala Hospitals, Zwolle, Overijssel, Netherlands.
Jacqueline PietersFertility clinic, Vivaneo Medisch Centrum Kinderwens, Leiderdorp, Netherlands.
Sjoerd ReppingCenter for Reproductive Medicine, Amsterdam Reproduction & Development Institute, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands.
Fulco van der VeenCenter for Reproductive Medicine, Amsterdam Reproduction & Development Institute, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands.
Monique H MochtarCenter for Reproductive Medicine, Amsterdam Reproduction & Development Institute, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionAt present, studies comparing intrauterine insemination in the natural cycle versus intracervical insemination in the natural cycle in women undergoing artificial insemination with donor sperm are scarce. METHODS AND ANALYSIS: We perform a randomised controlled non-inferiority trial among five secondary and tertiary fertility clinics in the Netherlands and one tertiary fertility clinic in Belgium. Women eligible for artificial insemination with donor sperm are included. We perform six cycles of artificial insemination with donor sperm within a time horizon of 8 months comparing intrauterine insemination in the natural cycle with intracervical insemination in the natural cycle. The primary outcome is ongoing pregnancy leading to live birth conceived within eight months after randomisation. Secondary outcomes are clinical pregnancy rate, miscarriage rate, multiple pregnancy rate, pregnancy complications (preterm birth, birth weight <2500 g, pregnancy induced hypertension, (pre-) eclampsia, Hemolysis Elevated Liver enzymes Low Platelets (HELLP)), time to ongoing pregnancy, direct and indirect costs. To demonstrate the non-inferiority of intracervical insemination with a margin of 12%, we need 208 women per arm. ETHICS AND DISSEMINATION: The study has been approved by the Medical Ethical Committee of the Academic Medical Centre and from the Dutch Central Committee on research involving human subjects (47330-018-13). The boards of the participating hospitals approved the study. Results will be disseminated through peer-reviewed publications and presentations at international scientific meetings. TRIAL REGISTRATION NUMBER: NTR4462.

Indexed as

Cervix UteriEquivalence Trials as TopicFemaleHumansInsemination, ArtificialMenstrual CycleRandomized Controlled Trials as TopicUterusdonor spermintracervical inseminationintrauterine inseminationreproductive medicine

Identifiers

PMID31340957
PMCPMC6661593

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.